All Open Protocols

Cancer clinical trials are research studies for developing better ways of detecting, treating, and eventually preventing cancer. By taking part in a clinical trial, you are among the first to receive new research treatments before they are widely available. Your participation in a clinical trial will influence the future direction of cancer care.

If you are interested in participating in a clinical trial, consult with your physician. Please note: clinical trials are not risk free. Patients must explore the options that are best for their individuals needs with the help of their physician.

Brain/CNS

Cancer Type: Medulloblastoma PNET
Research Base: COG
Protocol: COG ACNS0332

COG-ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Physician Summary:

Age 3 - 21 (inclusive); Newly Dx: RT+ Vincristine +/- Carboplatin f/b Maint +/- Continuous Isotretinoin

Cancer Type: Glioblastoma
Research Base: NCCTG
Protocol: NCCTG N0572

NCCTG N0572- A Phase I/II Trial of Sorafenib and CCI-779 in Patients with Recurrent Glioblastoma
Group 1 (Patients NOT Undergoing Surgery) for study 2 is permanently closed effective 9/27/11  

Physician Summary:

> Age 18; Recurrent Glioblastoma. Treatment: Oral Sorafenib and IV Temsirolimus

Cancer Type: High Grade
Research Base: COG
Protocol: COG ACCN0822

COG-ACNS0822: A Randomized Phase II/III Study of Vorinostat (IND# 71976) and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab (IND # 7921) and Temozolomide in Newly Diagnosed High Grade Glioma

Physician Summary:

< Age 22; Newly Diagnosed. Treatment: Vorinostat + RT  vs Temozolomide + RT vs Bevacizumab + RT f/b Bevacizumab Maintenance 

Cancer Type: Neuroblastoma
Research Base: COG
Protocol: COG ANBL0032

ANBL0032: Phase III Randomized Study of Chimeric Anti-GD2 in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Physician Summary:

< age 30; High Risk: Anti-GD2 Following ASCR

Cancer Type: Anaplastic Glioma
Research Base: NCCTG
Protocol: NCCTG N0577

N0577: Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma

Physician Summary:

> Age 18; Staging: Co-deleted 1p/19q Anaplastic Glioma; Treatment: RT vs Temozolomide alone vs RT with concomitant & Adjuvant Temozolomide.

Breast

Cancer Type: Breast Cancer Risk
Research Base: NSABP
Protocol: NSABP DMP-1

NSABP DMP-1: A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

Physician Summary:

Women > Age 35; Increased risk of breast cancer as determined by physician. Intervention: Evaluate Decision Making Process for this group of women

Cancer Type: Biomarker Study
Research Base: CALGB
Protocol: CALGB 70806

CALGB 70806 - Vitamin D and Breast Cancer Biomarkers (limited to Saint Mary's Health Care only)

Physician Summary:

< Age 55; FSH < 20; Staging: Vitamin D Levels; Treatment: Vitamin D /Placebo

Cancer Type: Breast - Cancer Control
Research Base: NCCTG
Protocol: NCCTG N10C2

NCCTG N10C2 - Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes

Physician Summary:

 > Age 18; Postmenopausal; History of Breast Cancer w/out Malignant Disease.

Cancer Type: Quality of Life
Research Base: ACOSOG
Protocol: U of M Family Study
 

The FAMILY (Facing A Maternal Illness in Latency Years) Project

Physician Summary:

Questionnaires for mothers who have been diagnosed with breast cancer within the past 6 months and their child/children ages 6-12

Cancer Type: Lymphedema Prevention
Research Base: CALGB
Protocol: CALGB 70305

70305: A Randomized Study to Prevent Lymphedema in Women Treated For Breast Cancer

Physician Summary:

Newly Diagnosed Stage I – IV: Study to Prevent Lymphedema. Tx: Step 1: Phsical Assessments and Questionnaires; Step 2: Education vs Education & PT Intervention.

Cancer Type: Early Stage Breast
Research Base: CTSU
Protocol: CTSU MA.32

CTSU NCIC MA.32 - A Phase III Randomized Trial of Metformin Versus Placebo on Recurrance and Survival in Early Stage Breast Cancer (QOL part of this study closes on November 4, 2011)

Physician Summary:

< Age 75; Staging: If high risk, Stage II except T0; Stage IIIA&C except T0 and T4. Treatment: Metformin vs Placebo

Cancer Type: Breast - Fatigue
Research Base: NSABP
Protocol: NSABP MA.32F

NSABP/NCIC CTC MA.32.F: Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

Physician Summary:

Companion study to CTSU MA.32. Bio-Specimen Collection and Patient Questionnaires.

Cancer Type: HER2 Positive Breast
Research Base: CTSU
Protocol: CTSU SCUSF 0806

CTSU SCUSF 0806: Phase II placebo-controlled trial of lisinopril and Coreg CR® to reduce cardiotoxicity in patients with breast cancer receiving (neo) adjuvant chemotherapy with trastuzumab (Herceptin ®)

Physician Summary:

> Age 18 and HER2 Positive; Adjuvant or Neo-Adjuvant Patients scheduled to receive Herceptin with or after primary chemotherapy. TX: Lisinopril or Coreg or Placebo

Cancer Type: DCIS
Research Base: NSABP
Protocol: NSABP B-43

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Physician Summary:

≥ age 18, Central HER2 Testing: RT +/- Trastuzumab

Cancer Type: Locally Recurrent
Research Base: RTOG
Protocol: RTOG 1014

(Available at Saint Mary's Health Care, Spectrum Health and Bronson Battle Creek) RTOG 1014: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

Physician Summary:

> Age 18; Staging: Locally Recurrent Breast Carcinmoa. Tx: Lumpectomy f/b 3D CRT

Cancer Type: WBI vs PBI
Research Base: NSABP
Protocol: NSABP B-39

B-39: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

Physician Summary:

< Age 50 if Stage 0-II; > Age 50 for Stage I & II if Node+ and/or ER-/PR- TX: Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI)

Cancer Type: Adjuvant, Node+
Research Base: SWOG
Protocol: SWOG S1007

SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less

Physician Summary:

Women > Age 18; Staging: 1-3 Positive Nodes; Oncotype Score Less than 25. Treatment: Chemotherapy + Endocrine Therapy vs Endocrine Therapy Alone.

Cancer Type: Post Neoadjuvant
Research Base: Sarah Cannon
Protocol: SCRI BRE 186

SCRI BRE 186: Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Physician Summary:

> Age 18; Staging: T1-T3, N1-N2, or MO (T1NOMO excluded). Treatment: Eribulin + Trastuzumab

Cancer Type: Node (+) or High-Risk Node (-)
Research Base: NSABP
Protocol: NSABP B-47

NSABP B-47 - A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

Physician Summary:

>Age 18; Resected Node(+) or High-Risk Node(-) HER2-Low (1+ to 2+ IHC). Treatment: Chemo (Physician’s choice: TC or  AC f/b WP) Alone vs Chemo +Trastuzumab

Cancer Type: Metastatic
Research Base: NCCTG
Protocol: NCCTG N0937

NCCTG N0937: Phase II Trial of Brostallicin and Cisplatin in Patients with Metastatic Triple Negative Breast Cancer

Physician Summary:

> Age 18; Stage IV;  Treatment: Cisplatin IV on Day 1, Brostacillin IV on Day 2 Followed by a GCSF on Day 3 in 3 Week Cycles

Cancer Type: Metastatic
Research Base: SWOG
Protocol: SWOG S0500

S0500: A Randomized Phase III Trial to Test the Strategy of Changing Therapy Vs. Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

Physician Summary:

Any T, Any N, M1; Doctor Decides Chemo Tx /> Circ. Tumor Cells (High Risk) May Be Randomized to Switch Chemo @ first f/u Assessment. Hormonal and Bio Txs Continued Unchanged

Cancer Type: Metastatic
Research Base: CTSU
Protocol: CTSU E2108

CTSU E2108 - A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Physician Summary:

> Age 18; Stage IV; Treatment: Optimal Systemic Therapy (physician prescribed) less than 20 Weeks in Length f/b Continued Systemic Therapy or Surgery and RT for primary tumor

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Cancer Control

Cancer Type: Breast Cancer Risk
Research Base: NSABP
Protocol: NSABP DMP-1

NSABP DMP-1: A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

Physician Summary:

Women > Age 35; Increased risk of breast cancer as determined by physician. Intervention: Evaluate Decision Making Process for this group of women

Cancer Type: Breast - Cancer Control
Research Base: NCCTG
Protocol: NCCTG N10C2

NCCTG N10C2 - Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes

Physician Summary:

 > Age 18; Postmenopausal; History of Breast Cancer w/out Malignant Disease.

Cancer Type: Biomarker Study
Research Base: CALGB
Protocol: CALGB 70806

CALGB 70806 - Vitamin D and Breast Cancer Biomarkers (limited to Saint Mary's Health Care only)

Physician Summary:

< Age 55; FSH < 20; Staging: Vitamin D Levels; Treatment: Vitamin D /Placebo

Cancer Type: Quality of Life
Research Base: ACOSOG
Protocol: U of M Family Study
 

The FAMILY (Facing A Maternal Illness in Latency Years) Project

Physician Summary:

Questionnaires for mothers who have been diagnosed with breast cancer within the past 6 months and their child/children ages 6-12

Cancer Type: Breast - Fatigue
Research Base: NSABP
Protocol: NSABP MA.32F

NSABP/NCIC CTC MA.32.F: Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

Physician Summary:

Companion study to CTSU MA.32. Bio-Specimen Collection and Patient Questionnaires.

Cancer Type: Lymphedema Prevention
Research Base: CALGB
Protocol: CALGB 70305

70305: A Randomized Study to Prevent Lymphedema in Women Treated For Breast Cancer

Physician Summary:

Newly Diagnosed Stage I – IV: Study to Prevent Lymphedema. Tx: Step 1: Phsical Assessments and Questionnaires; Step 2: Education vs Education & PT Intervention.

Cancer Type: Cognitive Functioning
Research Base: URCC
Protocol: URCC 10055

URCC 10055: Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up

Physician Summary:

Invasive Breast Cancer Stage I-IIIC or High-Grade Lymphoma; Chemo Naïve. Patient to complete three Questionnaires.

Cancer Type: HER2 Positive Breast
Research Base: CTSU
Protocol: CTSU SCUSF 0806

CTSU SCUSF 0806: Phase II placebo-controlled trial of lisinopril and Coreg CR® to reduce cardiotoxicity in patients with breast cancer receiving (neo) adjuvant chemotherapy with trastuzumab (Herceptin ®)

Physician Summary:

> Age 18 and HER2 Positive; Adjuvant or Neo-Adjuvant Patients scheduled to receive Herceptin with or after primary chemotherapy. TX: Lisinopril or Coreg or Placebo

Cancer Type: DCIS
Research Base: NSABP
Protocol: NSABP B-43

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

Physician Summary:

≥ age 18, Central HER2 Testing: RT +/- Trastuzumab

Cancer Type: Colon
Research Base: NSABP
Protocol: NSABP P-5

NSABP P-5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

Physician Summary:

> Age 18.  Staging: Stage I or II, adenocarcinoma of the colon. Treatment: Rosuvastatin (Crestor) vs Placebo

Cancer Type: Multisite
Research Base: MDA
Protocol: MDA 2007-0914A (PREDICT)

MD Anderson 2007-0914A - (PREDICT) A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment

Physician Summary:

Age 18-85 Years; New Course of Chemo w/Anthracycline. Treatment: BNP and Troponin I Prior to each Tx Cycle.

Cancer Type: Screening
Research Base: GOG
Protocol: GOG 8199

GOG 8199: Prospective Study of Risk-Reducing Salpingo-Oophrectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants

Physician Summary:

Substudy to GOG 0199 - Not available for new patients

Cancer Type: Pain Questionaire
Research Base: NCCTG
Protocol: NCCTG N08C1

N08C1: Paclitaxel-Associated Acute Pain Syndrome Natural History Study Please Note: Only Arms A & D are open.

Physician Summary:

≥ age 18; Any Staging: Standard of Care with Use of Paclitaxel

Cancer Type: Symptom Management
Research Base: MCCRC
Protocol: MCCRC RC08C6

RC08C6: White Wine for Appetite Loss: A Randomized, Controlled Non-blinded Trial

Physician Summary:

Cancer Type: Mindfulness Relaxation
Research Base: MDA
Protocol: MDA 2004-0024

Temp Closed! 2004-0024: Chemotherapy and Mindfulness Relaxation: A Randomized Trial At M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

Physician Summary:

Chemotherapy & Mindfulness Relaxation/Randomized Trial

Cancer Type: Assess ONJ
Research Base: SWOG
Protocol: SWOG S0702

SWOG S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients With Bone Metastasis Starting Zoledronic Acid Treatment

Physician Summary:

≥ age 18; Bone Mets: Assess ONJ in Patients receiving Zometa

Cancer Type: Mucositis
Research Base: NCCTG
Protocol: NCCTG N09C6

NCCTG N09C6: Randomized Double-Blind Study of Doxepin Rinse versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy with or without Chemotherapy. (Not available at Mercy Health Partners or Battle Creek Health System)

Physician Summary:

> Age 18; Painful Mucositis; Must be receiving Radiotherapy w/ 1/3 of oral cavity included in the radiation therapy fields. Treatment: Doxepin/Placebo

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Gastrointestinal

Cancer Type: Esophageal
Research Base: RTOG
Protocol: RTOG 0436

(Saint Mary's Only)  RTOG 0436: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Physician Summary:

> Age 18; T1N1M0; T2-4, Any N, M0; Any T, and N, M1a.  Treatment: Concurrent Radiation with Paclitaxel and Cisplatin, w/ or w/o Cetuximab

Cancer Type: Esophageal, GEJ or Gastric Cardia
Research Base: NCCTG
Protocol: NCCTG N0849

NCCTG N0849: Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, or Gastric Cardia

Physician Summary:

> Age 18. Staging: Locally Adv. Esophageal, GEJ or Gastric Cardia. Treatment: Docetaxel, Oxaliplatin, Capecitabine (Two 21 day Cycles) f/b 5-FU, Oxaliplatin, RT f/b Surgery or 5-FU, Oxaliplatin, RT f/b Surgery

Cancer Type: Gastric or Gastric Esoph. Junction
Research Base: SWOG
Protocol: SWOG S1005

SWOG S1005: A Phase II Study of MK-2206 as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer

Physician Summary:

> Age 18; Progression after 1st Line Reg. or Recurrent w/in 6 Mos of Adj Tx. Treatment: MK-2206 

Cancer Type: Adenocarcinoma
Research Base: MCCRC
Protocol: MCCRC I4T-MC-JVBT

MCCRC I4T-MC-JVBT: A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of mFOLFOX6 Chemotherapy Plus Ramucirumab Drug Product (IMC-1121B) versus mFOLFOX6 Plus Placebo for Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, or Stomach

Physician Summary:

≥ Age 18; Advanced Adenocarcinoma of the Esophagus, GE Junction or Stomach. Treatment: mFOLFOX6 +/- Ramucirumab 

Cancer Type: Colon
Research Base: NSABP
Protocol: NSABP P-5

NSABP P-5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

Physician Summary:

> Age 18.  Staging: Stage I or II, adenocarcinoma of the colon. Treatment: Rosuvastatin (Crestor) vs Placebo

Cancer Type: Colon
Research Base: CALGB
Protocol: CALGB 80702

CALGB 80702: A Phase III Trial of 6 Versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

Physician Summary:

FOLFOX +/- 6 cycles vs 12 cycles Celecoxib

Cancer Type: colorectal
Research Base: NSABP
Protocol: NSABP FC-6

NSABP FC-6 - A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mFOLFOX7 Plus Cetuximab for Unresectable Wild-Type K-RAS Colorectal Cancer with Metastases Confined to the Liver.  This study is open at Spectrum Health, Saint Mary's Health Care & Mercy Health Partners only

Physician Summary:

(Open at SH, SMHC and MHP Only) > Age 18; Staging: IV K-RAS Wild Type Unresectable Liver Mets; Treatment: Neoadjuvant mFOLFOX7 plus Cetuximab f/b liver mets resection

Cancer Type: Colorectal
Research Base: Sarah Cannon
Protocol: SCRI GI 154

SCRI GI 154: A Phase II Trial of Single Agent Axitinib as Maintenance Therapy for Patients with First Line Metastatic Colorectal Cancer (mCRC)

Physician Summary:

> Age 18: Life Expectancy Greater than 12 weeks; Staging: Stage IV. Treatment: FOLFAZ & Avastin f/b Axtinib as Maintenance Until Progression or Adverse Toxicities

Cancer Type: Rectal-Neoadjuvant
Research Base: SWOG
Protocol: SWOG S0713

S0713:  A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer

Physician Summary:

Neoadjuvant; Stage II-III; Oxaliplatin + Capecitibine  + Cetuximab f/b Oxaliplatin + Capecitibine + Cetuximab + RT f/b Surgery

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Genitourinary

Cancer Type: Prostate
Research Base: RTOG
Protocol: RTOG 0815

(Open at Spectrum Health, Saint Mary's Health Care and Bronson Battle Creek) RTOG 0815 - A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

Physician Summary:

> Age 18; Staging: T2b-T2c (intermediate risk); Treatment: Dose Escalated RT Alone vs. Dose Escalated RT Combined w/ Short Term Androgen Blockade

Cancer Type: Adenocarcinoma of the Prostate
Research Base: SWOG
Protocol: SWOG S1014

SWOG S1014: Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II

Physician Summary:

Adenocarcinoma of the Prostate; Staging: M1 Disease at time ADT intitiated. Treatment: Abiraterone Acetate + Prednisone until progression.

Cancer Type: Prostate NeoAdj High Risk
Research Base: CALGB
Protocol: CALGB 90203

CALGB 90203: Randomized Phase III Study Of Neo-Adjuvant Docetaxel And Androgen Deprivation Prior To Radical Prostatectomy Versus Immediate Radical Prostatectomy In Patients With High-Risk, Clinically Localized Prostate Cancer

Physician Summary:

≥ Age 18: LHRH + Docetaxel f/b Radical Prosatectomy w/staging PLND vs Radical Prostatectomy w/staging PLND

Cancer Type: Prostate
Research Base: SWOG
Protocol: SWOG S0925

SWOG S0925: Randomized Phase II Study of Androgen Deprivation Combined with IMC-A12 Versus Androgen Deprivation Alone for Patients with New Hormone-Sensitive Metastatic Prostate Cancer

Physician Summary:

Staging: M1 - Visceral Disease (Liver, Lung, or other Viscera); Bone Metastasis, Lymph Node Disease Not Encompassed within a Single Radiation Therapy Port. Treatment: Bicalutamide/LHRH Agonist +/- IMC-A12

Cancer Type: Wilms Tumor
Research Base: COG
Protocol: COG AREN0533

AREN0533: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Physician Summary:

< age 30, Newly Dx Higher Risk: VCR, AMD, DOXO per DD4A for 2 cycles + DD4A vs Regimen M

Cancer Type: Wilms Tumor
Research Base: COG
Protocol: COG AREN0534

COG-AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Physician Summary:

< age 30; All drugs commercially provided.  For Schema, contact pediatric nurses at GRCOP 616.391.1230.

Cancer Type: Renal
Research Base: COG
Protocol: COG AREN0321

AREN0321: Treatment of High Risk Renal Tumors

Physician Summary:

≤ age 30, Newly Diagnosed Stage I-IV, Chemo –vs- Surgery Only (Ancillary AREN03B2 Required)

Cancer Type: Renal
Research Base: SWOG
Protocol: SWOG S0931

SWOG S0931- EVEREST:  Everolimus for Renal Cancer Ensuing Surgical Therapy, a Phase III Study

Physician Summary:

> Age 18; Intermediate high risk and very high risk group. Treatment: Everolimus or Placebo

Cancer Type: Adv. Transitional Cell
Research Base: CALGB
Protocol: CALGB 90601

CALGB 90601 - A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma

Physician Summary:

> Age 18; Staging: Unresectable Locally Advanced or Metastatic. Treatment: Gemcitabine + Cisplatin + Bevacizumab/Placebo x6 Cycles f/b Maintenance Bevacizumab/Placebo

Cancer Type: Advanced Renal
Research Base: CALGB
Protocol: CALGB 90802

CALGB 90802: Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors

Physician Summary:

> Age 18; Advanced Renal Cancer; Prior Tx with TKI Required; Treatment: Everolimus/Placebo vs Everolimus/Bevacizumab

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Gynecologic

Cancer Type: Screening
Research Base: GOG
Protocol: GOG 8199

GOG 8199: Prospective Study of Risk-Reducing Salpingo-Oophrectomy (RRSO) and Longitudinal CA-125 Screening Among Women at Increased Genetic Risk of Ovarian Cancer: Extended Follow-Up of Select GOG-0199 Study Participants

Physician Summary:

Substudy to GOG 0199 - Not available for new patients

Cancer Type: Endometrial
Research Base: GOG
Protocol: GOG 0249

GOG 0249: A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy In Patients With High-Risk, Early Stage Endometrial Carcinoma 

Physician Summary:

> Age 18; Staging: High Risk,  Early Stage (I/II); Treatment: Pelvic RT vs Vaginal Cuff Brachytherapy f/b Paclitaxel/Carboplatin

Cancer Type: Ovarian/Primary Peritoneal
Research Base: GOG
Protocol: GOG 0212

GOG 0212: A Randomized Phase III Trial Of Maintenance Chemotherapy Comparing 12, Monthly Cycles Of Single Agent Paclitaxel Or Xyotax? (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse In Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Achieve A Complete Clinical Response To Primary Platinum/Taxane Chemotherapy.

Physician Summary:

Paclitaxel or Xyotax™ vs. No Treatment Until Documented Relapse

Cancer Type: Uterine
Research Base: GOG
Protocol: GOG 0261

GOG-0261: A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy -Naive Patients with Newly Diagnositc Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary

Physician Summary:

> Age 18; Stage I-IV persistent or recurrent carcinosarcoma, chemotherapy naive. Treatment: Paclitaxel & Carboplatin vs Ifosfamide w/ Mesna & paclitaxel, G-CSF Support Required.

Cancer Type: Ovarian, Fallopian Tube or Primary Peritoneal
Research Base: GOG
Protocol: GOG 0213

GOG 0213: A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed By Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary, and Fallopian Tube Cancer

Physician Summary:

≥ age 18; Recurrent: If surgery candidate, Randomize to +/- Surgery; For all Patients: Carboplatin/Taxol vs. Carboplatin/Taxol +/- Bevacuzimab

Cancer Type: Uterine-leiomysarcoma
Research Base: GOG
Protocol: GOG 0250

GOG 0250 - A Randomized Phase III Evaluation of Docetaxel and Gemcitabine Plus G-CSF With Bevacizumab Versus Docetaxel and Gemcitabine Plus G-CSF With Placebo in the treatment Of Recurrent or Advanced Leiomyosarcoma (LMS) of the Uterus

Physician Summary:

Advanced or Recurrent Leiomyosarcoma with documented Disease Progression. Treatment: Gemcitabine + Docetaxel + G-CSF + Bevacixumab/Placebo

Cancer Type: Endometrial
Research Base: GOG
Protocol: GOG 0258

GOG 0258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel VS. Carboplatin and Palitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Physician Summary:

≥ age 18; Debulked Stage III or IVA: Cisplatin/XRT f/b Carboplatin/Paclitaxel vs Carboplatin/Palitaxel

Head and Neck

Cancer Type: Recurrent or w/mets
Research Base: CTSU
Protocol: CTSU E1305

E1305: A Phase III Randomized Trial of Chemotherapy with or withoutBevacizumab In Patients with Recurrent Or Metastatic Head and Neck

Physician Summary:

≥ age 18; No Prior Chemo for Recurr or Mets: Cisplatin-doublet (phys. Choice) +/- Bevacizumab

Cancer Type: Head & Neck
Research Base: RTOG
Protocol: RTOG 1016

(Available at Saint Mary's Health Care and Bronson Battle Creek) RTOG 1016: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharnyx Cancer

Physician Summary:

> Age 18; Staging: T1-2, N2a-3, or T3-4 any N; Must be P16 Positive. Treatment: Cisplatin or Cetuximab w/ Concurrent RT

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Leukemia

Cancer Type: Cytogenetic Studies
Research Base: CALGB
Protocol: CALGB 8461

8461: Cytogenetic Studies In Acute Leukemia

Physician Summary:

Previously Untreated AML, ALL, MDS: Bone Marrow and Blood Samples (Ancillary CALGB 9665 Required)

Cancer Type: ALL T-Cell
Research Base: COG
Protocol: COG AALL0434

AALL0434: Intensified Methotrexate, Nelarabine (Compound 506U78; IND#52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL)

Physician Summary:

Age 0-30; Newly Diag. T-Cell ALL; Methotrexate, Nelarabine and Augmented BFM Therapy (Prerequisite AALL03B1)

Cancer Type: Leukemia
Research Base: COG
Protocol: COG AALL0433

AALL0433: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

Physician Summary:

  ≤ age 30; Initial Intermed-Risk Relapse of B-precursor: Standard VCR Dosing vs Intensive VCR Dosing

Cancer Type: ALL/LL
Research Base: COG
Protocol: COG AALL07P1

AALL07P1:  A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Physician Summary:

< Age 31; Relapsed B-precursor ALL, relapsed T-cell ALL and relapsed T-LL: Bortezomib w/Intensive Re-Induction Therapy

Cancer Type: AML
Research Base: COG
Protocol: COG ACCL0933

COG-ACCL0933: A Randomized Open-Label Trial of Caspofungin versus Fluconazol to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

Physician Summary:

AML Patients < Age 30; Caspofungin vs Fluconazol to Prevent Fungal Infections

Cancer Type: AML
Research Base: CTSU
Protocol: CTSU E2906

E2906:  Phase III Randomized Trial of Clofarabine as Induction and Post- Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age ≥ 60 Years) 

Physician Summary:

> Age 60; Newly Diagnosed AML. Treatment = Induction: Daunorubicin + Cytarabine vs Clofarabine f/b Consolidation: Cytarabine vs Clofarabine f/b Observation vs Decitabine, Option of Allogeneic STC for Some

Cancer Type: de novo AML
Research Base: COG
Protocol: COG AAML1031

A Phase III Randomized Trial for Patients with de novo AML using Bortezomib  and Sorafenib for Patients with High Allelic Ratio FLT3/ITD. 

Physician Summary:

< Age 30; Contact GRCOP pediatric nurses at 391-1230 for additional information on this study.

Cancer Type: AML
Research Base: COG
Protocol: COG AAML07P1

COG-AAML07P1: A Phase II Pilot Study of Bortezomib (PS-341, Velcade, IND #58,443) Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia

Physician Summary:

≤ age 21; Recurrent, Refractory or Secondary AML: Bortezomib Combined w/ Reinduction Chemotherapy

Cancer Type: APL
Research Base: SWOG
Protocol: SWOG S0535

SWOG S0535: A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Physician Summary:

>18: ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin

Lung

Cancer Type: Non-Small Cell
Research Base: SWOG
Protocol: SWOG S0720

Temp Closed! S0720: Phase II ERCC1 And RRM1-Based Adjuvant Therapy Trial In Patients With Stage I Non-Small Cell Lung Cancer (NSCLS)

Physician Summary:

≥ age 18; Stage 1A (w/ tumors > 2 cm) or Stage 1B: Genetic Testing for Risk.  Low Risk = Observation only. High Risk = Cisplatin/Gemcitabine

Cancer Type: Non-Small Cell
Research Base: RTOG
Protocol: RTOG 0813

(Available at Saint Mary's & Spectrum Health Only)  RTOG 0813 - Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients 

Physician Summary:

> Age 18; NSCLC Stage T1-2, N0, M0; Treatment: SBRT (Stereotactic Lung Radiotherapy)

Cancer Type: Non-Small Cell
Research Base: CTSU
Protocol: CTSU E1505

CTSU E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4cm) – IIIA Non-Small Cell Lung Cancer (NSCLS)

Physician Summary:

≥ age 18; Stage IB to IIIA: Cisplatin w/choice of Vinorelbine, Taxotere or Gemcitabine +/- Bevacizumab

Cancer Type: Non-Small Cell
Research Base: SWOG
Protocol: SWOG S0819

SWOG S0819 - A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Physician Summary:

> Age 18; Stage IV; Tx: Paclitaxel + Carboplatin + Bevacizumab (if appropriate) +/- Cetuximab

Cancer Type: Extensive Small-Cell
Research Base: SWOG
Protocol: SWOG S0802

SWOG S0802: A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC) -  (Platinum  Refractory Stratum closed to accrual)

Physician Summary:

E-SCLC/ > age 18; Extensive Stage, 2nd line SCLC: Topotecan +/- AVE0005

Cancer Type: Non-Small Cell
Research Base: CALGB
Protocol: CALGB 30801

CALGB 30801 – A Randomized Phase III Double Blind Trial Evalutating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Physician Summary:

Eligibility: > Age 18; Stage IIIB or IV; Treatment:  Squamous = Gemcitabine + Carboplatin + Celecoxib/Placebo; Non-Squamous = Pemetrexed + Carboplatin + Celecoxib/Placebo

Cancer Type: E-SCLC
Research Base: RTOG
Protocol: RTOG 0937

RTOG 0937-Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC). (Available at Spectrum Health and Saint Mary's Health Care Only)

Physician Summary:

> Age 18; Stage IV. Treatment: Prophylactic RT following SOC Chemotherapy 

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Lymphoma

Cancer Type: Hodgkin's Lymphoma
Research Base: COG
Protocol: COG AHOD0831

COG- AHOD0831 A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children with Newly Diagnosed High Risk Hodgkin Lymphoma

Physician Summary:

< Age 21; Stage III/IV w/ B Symptoms; Newly Diagnosed: See Fast Facts for Tx Schema. Call Pediatric Nurses at 616.391.1230 with questions.

Cancer Type: Hodgkin's
Research Base: SWOG
Protocol: SWOG S0816

SWOG S0816 - A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Early Interim FDG-PET Imaging

 

Physician Summary:

Age 18-60; Stage III/IV: ABVD x2 Cycles f/b PET f/b ABVD x4 or BEACOPP x6

Cancer Type: Non-Hodgkins Lymphoma
Research Base: CALGB
Protocol: CALGB 50901

CALGB 50901: A Phase II Trial of Ofatumumab in Previously Untreated Follicular Non-Hodgkin Lymphoma

Physician Summary:

> Age 18; WHO classification Grade 1, 2, or 3a w/out histologic transformation that is stage III, IV or bulky stage II & Low or Intermediate-Risk Disease; FLIPI Score. Treatment: Ofatumumab

Cancer Type: DLBCL
Research Base: SWOG
Protocol: SWOG S0806

SWOG S0806: A Phase I/II Trial of Vorinostat (SAHA) in Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL)

Physician Summary:

> Age 18; Stage II Bulky, Stage III or Stage IV Disease w/ an IPI or R-IPI Score Greater than 0. Treatment: RCHOP + Vorinostat

Cancer Type: ALL/LL
Research Base: COG
Protocol: COG AALL07P1

AALL07P1:  A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Physician Summary:

< Age 31; Relapsed B-precursor ALL, relapsed T-cell ALL and relapsed T-LL: Bortezomib w/Intensive Re-Induction Therapy

Melanoma

Cancer Type: Resected; High Risk
Research Base: CTSU
Protocol: CTSU E1609

This study is temp closed. E1609: Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon α-2b for Resected High-risk Melanoma

Physician Summary:

> Age 18; Stage IIIB-IV. Treatment: Ipilimumab vs Interferon Alpha. All physicians must complete study specific training prior to patient enrollment

Cancer Type: Malignant Melanoma
Research Base: NCCTG
Protocol: NCCTG N0879

Temp Closed to Premenopausal Women.  NCCTG N0879 – A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab with or without Everolimus for Therapy for Metastatic Malignant Melanoma

Physician Summary:

> Age 18; Stage IV; First & Second Line Therapy, Bevacizumab, Taxol, Carboplatin +/- Everolimus

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Myeloma

Cancer Type: Multiple Myeloma
Research Base: Sarah Cannon
Protocol: SCRI MM 23

SCRI MM 23 – A Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients with Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

Physician Summary:

> Age 18:  MM Who are not Candidates for High Dose Chemotherapy; First Line Treatment of Bendamustine + Bortezomib+ Dexamethasone

Sarcoma

Cancer Type: Ewings Sarcoma
Research Base: COG
Protocol: COG AEWS1031

COG-AEWS1031: A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma.

Physician Summary:

Age: 0-50; Non-Metastatic.  Contact GRCOP Pediatric Oncology nurses at 616.486.6156 for additional information.

Cancer Type: Rhabdomyo, Low Risk
Research Base: COG
Protocol: COG ARST0331

ARST0331: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Physician Summary:

Newly Dx, < 50 years old: VAC +/- XRT

Cancer Type: Rhabdomyosarcoma
Research Base: COG
Protocol: COG ARST0531

ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS).

Physician Summary:

< age 50; Newly Diagnosed: VAC vs VAC alternating w/ VI; Includes XRT

Cancer Type: Osteosarcoma
Research Base: COG
Protocol: COG AOST0331

AOST0331: A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy

Physician Summary:

≤ age 40; High Grade Osteosarcoma: Resectable/Histological Response to Pre-Operative Chemotherapy

Cancer Type: Osteosarcoma w/mets
Research Base: COG
Protocol: COG AOST06P1

AOST06P1: Feasibility and Dose Discovery Analysis of Zoledronic Acid with Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma

Physician Summary:

≤ age 40; No Prior Chemo; Feasibility & Dose Discovery Analysis of Zoledronic Acid with Concurrent Chemo

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis 

Unknown Primary

Cancer Type: Unknown Primary
Research Base: NCCTG
Protocol: NCCTG N0871

N0871: A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in previously Untreated Patients with Measurable Disease with Cancer of Unknown Primary (CUP)

Physician Summary:

> age 18; Carboplatin, Paclitaxel and Everolimus (RAD001) (Gene assay results provided at progression)

Cancer Type: Spine Mets
Research Base: RTOG
Protocol: RTOG 0631

RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis (Spectrum Health Only)

Physician Summary:

> Age 18; Stage IV - Multisite. Treatment: Image-Guided SBRT vs External Beam RT for Localized Spine Metastasis