Clinical Trials

Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. We provide you access to a wide variety of clinical trials and continue to open new trials as they become available. We are committed to providing innovative treatments at our community clinics.

 

BRAIN

NRG BN-001: Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Eligibility:
https://clinicaltrials.gov/ct2/show/NCT02179086

NRG-CC001: A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients with Brain Metastases.

NRG-CC003: A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer.

BRAIN-CANCER CONTROL

Alliance A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with Glioblastoma Multiform Eligibility: Stable GBM completed SOC RT and concurrent chemo allowed; > 6 score on BFI.
http://www.cancer.gov/clinicaltrials/search/view?cdrid=746035&version=patient

Alliance A071102: A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation.

BREAST NEO-ADJUVANT

Alliance A011106 (ALTERNATE):  Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients with Stage II-III Breast Cancer Undergoing SurgeryEligibility:  Clinical T2-T4c, any N, MO; patients w/ contralateral DCIS and/or invasive breast ca not eligible; multifocal/multi-lesion pts not eligible if >1 lesion is invasive breast ca in same breast; ER+, HER2-.Treatment: Arm I: Anastrozole 1 mg QD, days 1-28, every 4 wks x 6 cycles Arm II: Fulvestrant 500 mg IM, days 1 and 15 of cycle 1 and day 1 of cycles 2-6, every 4 weeks x 6 cycles. Arm III:  Anastrozole and Fulvestrant.         

BREAST-ADJUVANT

Limited site participation (NW clinic only)ML25749 NeuVax: Combination Immunotherapy with Herceptin and the HER2 vaccine NeuVax E75 in Low and Intermediate HER2-expressing Breast Cancer Patients to Prevent RecurrenceTreatment: Herceptin + NeuVax/GM-CSF or Herceptin + GM-CSF after SOC therapy.

SWOG S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer.
http://www.cancer.gov/clinicaltrials/search/view?cdrid=738280&version=HealthProfessionalTreatment:
Everolimus for 1 year + appropriate endocrine therapy for 5 years VS Placebo for 1 year + appropriate endocrine therapy for 5 years.

BREAST- LOCALLY ADVANCED OR METASTATIC

Limited site participation (NW clinic only)Novartis IRB 15690: CLEE011X2106: A phase Ib trial of LEE011 in combination with everolimus (RAD001) and exemestane in the treatment of postmenopausal women with hormone receptor positive HER2 negative locally advanced or metastatic breast cancerEligibility: Recurrence while on or 12 mos after end of adjuvant treatment w/ Letrazole or anastrozole OR progression while on or w/in one month of end of letrozole or anastrozole for locally advanced or metastatic disease (letrozole or anastrazole do not have to be last treatment prior to enrollment). Pts. must not have received more than 1 chemotherapy line for advanced breast ca. PI: Jacqueline Vuky, MD

Can enroll patients undergoing treatment for advanced disease to pre-screen tissue for GPNBCelldex
IRB 10849: Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study)Eligibility: Male and female pts w/ triple-negative, metastatic, histologically or cytologically confirmed breast cancer; triple-negative status according to the following criteria: Overexpression of GPNMB in advanced setting (determined by central lab after consent obtained; 0 or 2 prior chemo regimen for advanced breast ca; prior receipt of anthracycline-containing chemotherapy in any setting unless anthracycline therapy is not clinically indicated; must have received prior receipt of taxane-containing chemo in any setting; Patients who have had  progression/recurrence of breast cancer must be within 3 months of completion of neoadjuvant or adjuvant chemotherapy are ineligible. Treatment: CDX-011(supplied) or capecitabine (commercially supplied). PI: Jacqueline Vuky, MD

Merck IRB 15176: A Randomized Open-Label Phase 3 Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC)Eligibility: Have received 1 or 2 prior systemic treatments for metastatic breast ca and have progressed on most recent therapy; previously treated w/ anthracycline and/or taxane in neoadjuvant or metastatic setting; measurable disease; newly obtained core or excisional biopsy from a metastatic, not previously irradiated, tumor lesion. PI: Kathleen Kemmer, MD Genentech IRB 15006: A Phase III, Double-Blind Placebo-Controlled, Randomized Study of Taselisib plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women with Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer who have Disease Recurrence or Progression During or After Aromatase Inhibitor TherapyInclusion:  Histologically or cytologically confirmed invasive, ER+ metastatic or inoperable locally advanced breast cancer; patients for whom endocrine therapy is recommended and cytotoxic chemo is not indicated at time of study entry; evidence of recurrence or progression to most recent systemic therapy; evidence or recurrence or progression on or w/in 12 months of end of adjuvant tx w/ an AI or progression while on or w/in 1 month of end of prior AI treatment for locally advanced or MBC (the AI does not have to be the most recent treatment); positive for PIK3CA mutation (tissue must be sent to study lab for testing and can be sent prior to recurrence or progression). Treatment: Taselisib 4 mg QD + Placebo or Fulvestrant  PI: Jacqueline Vuky, MD

IRB 15366: Oncothyreon Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast CarcinomaInclusion: Have received previous treatment w/ taxane, trastuzumab, pertuzumab, and T-DMI; see protocol for criteria for previous treatments; progression after last systemic therapy; measureable or non-measurable dz; creatinine clearance > 50; must have no evidence of CNS mets OR untreated CNS mets not needing immediate local therapy OR previously treated CNS mets. Exclusion: see protocol for exposure exclusions for cumulative doses of anthracyclines. Treatment: Capecitabine, Trastuzumab,and either ONT-380 or placebo. PI: Kathleen Kemmer, MD    

GI-COLON/RECTUM

Vitamin D in Colorectal Chemotherapy Patients: Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Adjuvant Chemotherapy for Stage III Colorectal Cancer Eligibility: Stage III colon or stage II/III rectal cancer that will receive adjuvant chemotherapy but not yet started; baseline vitamin D level below 52 ng/ml. Treatment: 50,000 IU orally weekly or 2,000 IU orally daily.                                       

GI-GASTRIC

IRB 15706 JAVELIN: EMR100070-007: A Phase III open-label, multicenter trial of maintenance therapy with avelumab (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-esophageal junctionInclusion: Tumor tissue suitable for PD-L1 assessment; measureable disease. No prior therapy w/ any antibody or drug targeting T-cell coregulatory proteins; no tumor shown to be HER2+ allowed; treated brain mets allowed; no significant acute or chronic infections (see protocol for exclusions); no prior organ transplant including allogeneic or stem-cell transplant. Treatment: Induction includes oxaliplatin w/ 5-FU or oxaliplatin w/ capecitabine both for up to 12 weeks. If no disease progression, patients eligible to be randomized into maintenance phase with avelumab or continue the same chemo regiment from induction phase. PI: Gina Vaccaro, MD

GI-HEPATOCELLUAR CARCINOMA

IRB 11746: Eli Lilly I4T-MC-JVDE: Randomized, Double-Blind, Placebo-Controlled, Phase 3Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib Eligibility (see protocol for full list of inclusion/exclusion criteria): Diagnosis of HCC based on histopathologic or cytologic findings or diagnosis of cirrhosis and HCC w/ classical imaging characteristics (see protocol for definition); received sorafenib for at least 14 days; disease  progression during or after discontinuation of sorafenib or dc’d sorafenib because of intolerance; patient received sorafenib as only systemic therapeutic intervention for advanced HCC; pt has > 1 measureable lesion by RECIST 1.1 that has not been treated by locoregional therapy; Child-Pugh score of < 7; Pt has BCLC Stage C disease or BCLC Stage B not amenable to locoregional therapy or refractory to locoregional therapy; pt has baseline AFP > 400; pt must not have fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma; no previously documented brain mets, leptomeningeal disease, or uncontrolled spinal cord progression; no history of or current hepatic encephalopathy or clinically meaningful ascites; no ongoing or recent (< 6 mos prior to rando) hepatorenal syndrome; no prior liver transplant. Treatment: Ramucirumab/Placebo 8mg/kg iv D1 q 14days. PI: Gina Vacarro, MD

IRB 15077: Astellas 9785-CL-3021: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects with Advanced Hepatocellular Carcinoma  Eligibility: Advanced HCC of any etiology; BCLC stage B or C; lesions not amenable to local therapies which may be beneficial; Child-Pugh Class A; received prior treatment for HCC w/ sorafenib or anti-VEGF and has confirmed progression or treatment discontinued due to drug-related toxicity; may have received 1 line of systemic investigational therapy after sorafenib/anti-VEGF; toxicities from prior CHH therapy < grade 1; ECOG 0-1. Treatment: Enzalutamide vs. placebo. PI: Gina Vacarro, MD                           

IRB 15816: Merck Keynote-224 A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Previously Systemically Treated Advanced Hepatocellular CarcinomaEligibility: Histological or cytologically confirmed HCC; BCLC Stage C or B; Child-Pugh class A; measureable disease; ECOG 0 or 1; Treatment: Pembrolizumab 200 mg Q3W. PI: Gina Vacarro, MD                                

GI-LIVER

Temporary closure to enrollment due to poor accrual NRG-GI001: Gemcitabine Hydrochloride and Cisplatin with or Without Radiation Therapy in Treating Patients with Localized Liver Cancer That Cannot Be Removed By Surgery Eligibility: http://www.cancer.gov/clinicaltrials/search/view?cdrid=763371&version=HealthProfessional

GI-PANCREAS

IRB 11256 OHSU IIT: Phase 2 Study of Preoperative chemotherapy with ABRAXANE and Gemcitabine followed by chemoradiation for Borderline Resectable or Node-positive Pancreatic Cancer Inclusion: Histologically or cytologically confirmed adenocarcinoma of the pancreas and must be localized and classified as borderline resectable by AHPBA/SSO/SSAT consensus criteria (10) or be node-positive via CT or endoscope ultrasound; must have measurable disease; no prior therapy for pancreatic cancer; ECOG < 1; subjects w/ plastic biliary stents excluded but metal stents allowed. Treatment: Pre-operative ABRAXANE + gemcitabine x 2 cycles. Chemoradiotherapy 5-FU + IG-IMRT Post-operative Gemcitabine + ABRAXANE for 4 cycles. PI: Gina Vaccaro, MD Co-I: Eric Anderson, MD   

GI-GASTRIC

IRB 15706 JAVELIN: EMR100070-007: A Phase III open-label, multicenter trial of maintenance therapy with avelumab (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-esophageal junctionInclusion: Tumor tissue suitable for PD-L1 assessment; measureable disease. No prior therapy w/ any antibody or drug targeting T-cell coregulatory proteins; no tumor shown to be HER2+ allowed; treated brain mets allowed; no significant acute or chronic infections (see protocol for exclusions); no prior organ transplant including allogeneic or stem-cell transplant. Treatment: Induction includes oxaliplatin w/ 5-FU or oxaliplatin w/ capecitabine both for up to 12 weeks. If no disease progression, patients eligible to be randomized into maintenance phase with avelumab or continue the same chemo regiment from induction phase. PI: Gina Vaccaro, MD

GU-BLADDER

ONLY OPEN AT CHM (CHO Patients must be referred to Jeremy Cetnar)
IRB 11749: Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual Checkpoint Inhibition in Platinum Resistant Metastatic Urothelial CarcinomaInclusion Criteria:  Histologically or cytologically confirmed metastatic urothelial carcinoma of the bladder or mixed histology bladder. Progression during or after platinum-based chemotherapy or has recurred during or w/in 1 year of platinum-based neoadjuvant or adjuvant therapy. Prior therapy with ≥ 1 chemotherapy. ECOG 0 or 1. Completion of all cancer therapy and recovered (ie, Grade ≤ 1 or baseline and/or Grade ≤ 2 neuropathy or Grade ≤ 2 alopecia). Able to provide tissue from archived sample or newly obtained core or excisional biopsy not previously irradiated. Exclusion Criteria:  Prior malignancy (see protocol for exceptions). See protocol for exclusions of prior therapy. Requires or receiving anticoagulation with warfarin or equivalent w/in 28 days of first dose of study drug. Hemoglobin < 8.0 g/dL estimated creatinine clearance of < 30 mL/min (see protocol for other lab parameters). Treatment: Arm 1 – Pembrolizumab 200 mg IV infusion every 3 weeks; Arm 2 – ACP-196 100 mg PO BID plus Pembrolizumab 200 mg IV infusion every 3 weeks. PI: Jeremy Cetnar, MD                                                 

GU - PROSTATE

SWOG S1216: Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer   Eligibility: Newly diagnosed distant metastatic adenocarcinoma of the prostate must be diagnosed prior to initiation of androgen deprivation; measureable or non-measureable disease; pts. w/ brain mets not eligible; prior neoadjuvant and/or adjuvant HT < 36 mos. allowed. Must not have received ketoconazole, aminoglutethimide or abiraterone acetate; no prior chemo for metastatic prostate ca; at least 2 yrs. since last ADT or chemo in the neoadjuvant or adjuvant setting; prior palliative RT, prior surgery and current/planned bone targeting agents allowed; must not have plans to receive LHRH antagonists; no more than 30 days since prior medical castration; must not have received bilateral orchiectomy; PSA > 2.
http://www.cancer.gov/clinicaltrials/search/view?cdrid=747762&version=HealthProfessionalTreatment
LHRHa + TAK-700 vs. LHRHa + Bicalutamide

ALLIANCE A031201: Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients with Castration-Resistant Metastatic Prostate Cancer Eligibility: Progressive castration-resistant metastatic adenocarcinoma prostate cancer w/o neuroendocrine differential or small cell features; measureable or non-measurable disease; progressive disease defined as PSA progression by a minimum of 2 rising PSA levels > 1 week w/ second rise > 4 weeks since flutamide or > 6 weeks since bicalutamide or nilutamide or soft tissue progression (see protocol for definition) or  bone disease progression defined by PCWGS w/ 2 or more new lesions on bone scan; subjects can have had no treatment w/ prior taxane-based chemo for metastatic disease; no prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor. Treatment: Enzalutamide vs Enzalutamide + Abiraterone + Prednisone                                                                    

HEAD AND NECK

Open at CHO Gresham and NW Portland Clinic onlyNRG-HN003: A Randomized Phase II Trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

GYN

Enrollment pending IRB approval GOG-0238: A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

GOG-0263: A Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Enrollment pending IRB approval GOG-0277: A Phase III Randomized Trial of Gemcitabine (NSC#613327) Plus Docetaxel (NSC#628503) Followed by Doxorubicin (NSC#123127) Versus Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

NRG-GY004: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (Olaparib, Cediranib and BRCA testing provided)

Enrollment pending IRB approval NRG-GY005: A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-Resistant or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS) (Olaparib and Cediranib provided)

NRG-GY006: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer (Triapine provided)

Tesaro Inc. PR-30-5017-C: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy (Niraparib provided)

LUNG-ADJUVANT

IRB 12012: GO29527 A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezouzumab (Anti-PD-L1 Antibody) Compared with Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in PD L1-Selected patients with Completely Resected Stage IB-IIIA NSCLC Eligibility for Enrollment Phase: PD-L1 expression of TC3 or IC3; Stage IB-IIA; complete resection of NSCLC 6-12 weeks prior to enrollment; eligible to receive cisplatin-based chemo. Treatment: Cisplatin-based chemotherapy based on investigator choice (up to 4 cycles). Randomization Phase (after up to 4 cycles of cisplatin-based chemotherapy) treatment: MPDL3280A vs. Best Supportive Care. PI: Dr. Tolba       

LUNG-ADVANCED

Enrollment open at GS, pending at MHNRG-CC003: A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer

IRB 11845: GO29431A Phase III, Open Label, Randomized Study of MPDL3280A (anti-pdl1 antibody) Compared with Cisplatin or Carboplatin + Pemetrexed for PDL1- Selected Chemotherapy Naive Patients with Stage IV Non -Squamous Non-Small Cell Lung CancerEligibility: ECOG 0-1; no prior treatment for stage IV unless received EGFR TKI or ALK inhibitor; previous history of treatment asymptomatic CNS mets allowed; Tumor PD-L1 expression (TC1 or IC3); measureable disease. Treatment: MPDL3280A vs.platinum-based regimen (carboplatin or cisplatin per investigator discretion) + pemetrexed. PI: Dr. Cetnar

IRB 11851: GO29437A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of MPDL3280A (Anti PD-L1 Antibody) in Combination with Carboplatin + Paclitaxel or MPDL3280A in Combination with Carboplatin + Nab-Paclitaxel versus Carboplatin + Nab-Paclitaxel in Chemotherapy Naïve Patients with Stage IV Squamous NSCLCEligibility: Stage IV squamous NSCLC; no prior treatment except EFGR TKI or ALK inhibitor; treated asymptomatic CNS mets allowed; known PD-L1 tumor status. Treatment: Arm A: MPDL3280A + carboplatin x 4 to 6 cycles + maintenance MPDL3280A. Arm B: MPDL3280A + nab-paclitaxel x 4 to 6 cycles + maintenance MPDL3280A. Arm C: Carboplatin + nab-paclitaxel.PI: Dr. Cetnar

RTOG 1306: A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III (NSCLC)Eligibility: Histologically or cytologically confirmed non-squamous NSCLC; unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease. RX: EGFR mutation randomized to RT and chemo (standard treatment) vs. erlotinib x 3 mos. followed by RT and chemo. ALK rearrangement RT and chemo (standard treatment) vs. crizotinib x 3 mos. followed by RT and chemo. (ERLOTINIB and CRIZOTINIB SUPPLIED)

SWOG S1400 Lung-MAP: S1400 Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer (Patients can be pre-screened while they are undergoing first-line treatment)Eligibility: Squamous cell lung cancer (no mixed histology); Stage IIIB or IV; pts must have progressed after receipt of 1 front-line platinum metastatic chemo regimen; pts. Must have adequate tumor tissue from FNA or core bx; no known EGFR mutation or ALK fusion; measureable dz. Treatment:1. Tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm 1 anti-B7H1 monoclonal antibody MEDI4736. 2. PI3KCA positive randomized to Arm 1 PI3 kinase inhibitor GDC-0032 vs Arm II Docetaxel. 3. CDK4/6, CCND1, CCND2, and CCND3 positive randomized to Arm 1: palbociclib vs Arm II: Docetaxel. 4. FGFR1, FGFR2, and FGFR3 positive randomized to Arm 1: FGFR inhibitor AZD4547 vs Arm II: Docetaxel. 5. HGF/c-METpositive randomized to Arm 1: rilotumumab + erlotinib vs Arm 2: Erlotinib.                   MULTIPLE MYELOMA

Temporary accrual closure SWOG S1211: A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or Without Elotuzumab (NSC-764479) for High Risk Multiple Myeloma (HRMM) (Phase II)Inclusion: Must have high-risk MM based on 1 or more of the following criteria (at time of initial diagnosis prior to any chemotherapy): poor risk genomic signature according to University of Arkansas 70 gene model and/or translocation 14;16 and or 14;20 and or deletion 17p by FISH or cytogenetics and/or primary plasma cell leukemia and/or  LDH > 2 x IULN and/or 1q21 amplification by FISH and/or high risk by the SKY92 signature. Pts with non-secretory MM or known amyloidosis not eligible;  must have received 1 prior cycle of non-investigational chemo; must have measurable dz; must have received 1 prior cycle of non-investigational chemo; must not have active involvement of CNS; Zubrod < 2; ANC > 1000 w/o growth factor support; see protocol for other lab requirements. Treatment: Arm 1:  Bortezomib, lenalidomide, and dexamethasone every 21 days for 8 courses followed by maintenance bortezomib, lenalidomide, and dexamethasone.  Arm 2: Bortezomib, lenalidomide, dexamethasone, and elotuzumab every 21 days for 8 courses followed by maintenance bortezomib, lenalidomide, dexamethasone, and elotuzumab.    ONLY OPEN AT CHM (CHO PATIENTS MUST BE REFERRED TO EMMA SCOTT)The Dana/ Faber / IFM: Phase III RCT of RVD upfront (3 cycles) followed by stem cell collection and randomization to RVD for another 5 cycles and maintenance revlimid until progression at which time ASCT will be performed as salvage versus, RVD for 3 cycles, stem cell collection and ASCT followed by 2 cycles of RVD consolidation followed by revlimid maintenance.From PI Emma Scott: “This is for patients under the age of 65. Unfortunately, we were not able to have CHO enroll directly to this study, and thus I would encourage you to consider sending your newly diagnosed transplant eligible patients to CHM so that we can successfully enroll to this exciting international study which is a top priority for the myeloma community”.

MISC. – HEMATOLOGY

Incyte IRB 11213: Prospective, Non-Interventional Study of Disease Progression and Treatment of Patients with Polycythemia Vera in United States Academic or Community Clinical Practices (REVEAL) Eligibility: Under care by physician for the current care of PV including but not limited to watchful waiting, ASA 81 mg or greater, antithrombotic therapy, PHL,HU, interferon (recombinant or pegylated), busulfan, anagrelide. Excluded: patients in an active clinical trial in which treatment is blinded; life expectancy < 6 months: diagnosis of MF, secondary AML, and/or MDS; history of or active plan to proceed w/ SCT in next 3 months; splenectomy.  OBSERVATIONAL ONLY STUDY.PATIENTS CAN ENROLL AT ANY POINT DURING THEIR DIAGNOSIS.PI: Kevin Yee, MD

Evaluation Cancer Survivorship Care Models: Study is conducted by a team at GW University Milken Institute School of Public Health and the School of Medicine and Health Services.
Eligibility: Survivors of non-metastatic breast, prostate, or colorectal cancer and who have completed active treatment (surgery, radiation, chemotherapy). Survivors who have not received post treatment clinic visit through Legacy Health Survivorship clinic.