EINSTEIN HEALTHCARE NETWORK CANCER CENTER ACTIVE CLINICAL TRIALS 1 TABLE OF CONTENTS PAGE Studies by Organ/System 3 Brain 4 - 6 Breast – Neoadjuvant/Adjuvant 6 Breast – Advanced/Metastatic 7-8 Gastrointestinal – Colorectal – Adjuvant 9 Gastrointestinal –Advanced, Metastatic 10 Gastrointestinal –Hepatocellular 11 Gastrointestinal –Pancreatic 12-13 Genitourinary – Prostate 14 Gynecological 15-16 Head and Neck 17 Myeloma 18-20 Lung – NSCLC 21-22 Lung – SCLC/Thymoma, Thymic Carcinoma/Mesothelioma 23-24 Supportive care 25 Multiple cancer diagnoses 26 Trials pending activation 27 ECOG Path. Coordinating Ctr Information “NEW” 10/24/2014 2 BRAIN PROTOCOL CONTACTS Radiation Oncology Investigator – Kenneth Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316 No active studies at this time. 3 BREAST PROTOCOL CONTACTS MEDICAL ONCOLOGY Investigator – Mark S. Morginstin, DO 215-456-3880 Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295 RADIATION ONCOLOGY Investigator – Angelica T. Montesano, MD 215-456-6280 Coordinator – Jeff Mealy, RN 215-456-6316 STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY ADJUVANT NRG BR-003/ A Randomized Phase III Trial of Adjuvant Therapy Arm 1: CIRB-005 Comparing Doxorubicin Plus Cyclophosphamide Followed by Doxorubicin 60 mg/M2 IV Weekly Paclitaxel with or without Carboplatin for Node- Cyclophosphamide 600 mg/m2 IV # Pts: _____ Positive or High-Risk Node Negative Invasive Breast Cancer Q 2 Weeks X 4 cycles Eligibility: Unilateral breast IDC: pT1-3; pN0 – pN3b, Followed by: underwent mastectomy or clear margins on lumpectomy/re- Paclitaxel 80 mg/m2 IV weekly x 12 doses excision; ER, PR, & HER2 negative (please see pgs. 14-15 of protocol for specifics). < 60 days from last surgery to Arm 2: randomization. Adequate organ function/lab values (see pgs. 15 Doxorubicin 60 mg/M2 IV & 16 of protocol); Please refer to section 3.3, pgs. 16 & 17 for Cyclophosphamide 600 mg/m2 IV exclusion criteria details. Initial approval 3/21/2016 Q 2 Weeks X 4 cycles Followed by: CIRB Approval expires 2/17/17 Paclitaxel 80 mg/m2 IV weekly x 12 doses and Carboplatin AUC 5 IV Q 3 weeks 4 STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY ADJUVANT RTOG 1014 Partial Breast Re-Irradiation (PBrI) Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 3D-Conformal External Beam A Phase II study of Repeat 1.5 GY x 15 (BID) to 45 Gy Total 1.5 GY x 15 (BID) to 45 Gy Total Breast Preserving Surgery and Patient Population: 3D-Conformal � Histopathologic confirmation via lumpectomy of local in-breast Partial Breast Re-Irradiation ipsilateral recurrence (PBrI) for Local Recurrence of � Final breast surgery (lumpectomy and/or final re-excision) within Breast Carcinoma 42 days prior to study entry; � Initial lumpectomy followed by whole breast radiation >1 year Closed to accrual 6/18/13 prior to study entry; � Ipsilateral breast mammogram and MRI within 120 days prior to study entry. Contralateral breast mammogram within 12 months of study entry. � Negative histologic margins of resection, no tumor on ink, following breast-preserving surgery of local recurrence. RTOG 1005 Patient Population: ARM 1: Standard fractionation pStage 0, I, II Breast Cancer resected by lumpectomy Whole Breast 50.0 Gy/25 fractions/2.0 Gy daily ypStage 0, I,II Breast Cancer resected by lumpectomy that Optional fractionation of 42.7Gy in 16 fractions permissible A PHASE III TRIAL OF followed neoadjuvant systemic therapy Sequential Boost 12.Gy/6 fractions/2.0 Gy daily or ACCELERATED WBI WITH 14.0Gy/7fractions/2Gy daily HYPOFRACTIONATION PLUS ARM 2: Hypofractionation (15 fractions total) CONCURRENT BOOST Whole Breast 40 Gy/15 fractions/2.67 Gy daily Vs. STANDARD WBI Concurrent boost 48.0 Gy/3.2 Gy daily PLUS SEQUENTIAL BOOST FOR EARLY-STAGE BREAST CANCER 5 BREAST – Advanced/Metastatic E2112 A Randomized Phase III Trial of Endocrine Therapy plus Arm A: CIRB-004 Entinostat/Placebo in Postmenopausal Patients with Exemestane 25 mg PO daily x 28 days Hormone Receptor-Positive Advanced Breast Cancer Entinostat 5 mg PO days 1, 8, 15, & 22 # Pts. = _____ Eligibility:ER or PR (+) hist. confirmed adeno ca; must be HER2 Arm B: Initial NCI-CIRB AEHN approval 2/4/2016 neg.; Stage III/locally advanced or metastatic not suitable for Exemestane 25 mg PO daily x 28 days therapy of curative intent. Meas or non-meas disease evaluated < Placebo 5 mg PO days 1, 8, 15, & 22 Expires May 20, 2016 4 wks. Please see eligibility checklist for complete entry criteria [protocol section 3.1, pages 19-22]. A cycle = 28 days 6 GI PROTOCOL CONTACTS – ANAL, COLORECTAL, ESOPHAGEAL, GASTRIC, HEPATOCELLULAR, PANCREATIC, & GIST Medical Oncology: Investigator – John Leighton, MD 215-456-3880 Coordinator – Joann R. Ackler, RN, OCN, CCRP 215-456-8295 Radiation Oncology: Investigator – Kenneth Zeitzer, MD 215-456-6285 Coordinator – Jeff Mealy, RN 215-456-6316 GASTROINTESTINAL STUDIES – Esophagus & Gastric – No active studies at this time. 7 GASTROINTESTINAL – Adjuvant/Resected Colon C80702 Phase III Trial of 6 vs. 12 Treatments of Adjuvant Folfox + Arm A: 6 cycles FOLFOX* + Celecoxib/placebo Stage III Celecoxib/Placebo for Patients with Resected Stage III Colon (400 mg daily) Q 2 weeks Cancer (H) N-4285 Arm B: 12 cycles FOLFOX* + Eligibility: Hist. proven Adenocarcinoma; margin > 12 cm from Celecoxib/placebo (400 mg daily) Q 2 weeks # Pts. 5 anal verge & completely resected – R0 resection must be in Accrual goal = 10 / 2,500 operative report; > 1 + lymph node or N1C [see AJCC v. 7]; *Oxaliplatin – 85 mg/m2 IV over 2 hrs, followed synchronous colon primaries OK; PS 0-2; adequate hematologic, by Study Nurse: Joann Ackler renal, & hepatic function; NO -- evidence of residual nodal or *Leucovorin 400 mg/m2 IV over 2 hrs, followed metastatic disease; NSAIDS or ASA use > 3 x/wk; prior or by Closed to accrual concurrent malignancy except in situ skin cancer unless NED > 5 *5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 11.20.15 yrs; neuro-toxicity > Gr 2; history UGI ulcers, bleed, or CIV over 46-48 hrs. perforation x 3yrs; uncontrolled HTN, unstable angina, any history Update #7 approved 3/16/2015 of MI or CVA, NYHA class III/IV CHF; allergy to sulfonamides, NOTE: Treatment must begin > 21 and < 56 IRB Approval Expires celecoxib, NSAIDS. days after definitive resection. September 17, 2016 8 GASTROINTESTINAL – Metastatic Colorectal STUDY# TITLE and ELIGIBILITY CRITERIA THERAPY 2012-PT023-V3.4 Phase III Double-Blinded, Placebo Controlled Study of Study drug (MABp1/placebo) WIRB # 20120762 XilonixTM for Improving Survival in Metastatic Colorectal 7.5 mg/kg IV over 1 hour (+/- 15 minutes) Cancer Patients with Cachexia Q 2 weeks # Pts. =1 (under v2.4); 3 (under v3.4) 1 hour observation will follow each infusion Eligibility: Path. Confirmed metastatic or unresectable, refractory colon cancer (refer to protocol pg 30 for required prior therapies); PS = 0-2; Weight loss in past 6 months must be < 20%; most *all subjects will receive BSC (best supportive care) Total = 4 recent anti-cancer therapy must be > 2; adequate organ function – Accrual goal = 8 / 650 + ++ see specific lab parameters pg 29; serum K & Mg levels must be WNL – OK to replenish to normal prior to enrollment; refer to Study nurse: Joann Ackler pg 31 for specific cardiac status criteria; NO active infections, HIV, Hepatitis B or C; NO TB history (latent or active) or + IGRA; AEs from prior trt must be < grade 1. Restricted therapies:at least 2 weeks since last therapy WIRB Initial Approval Date – including; XRT, chemotherapy, immunotherapy, surgery, 5.13.2013, hormonal therapy or targeted biologics; at least 4 weeks since Version 3.4 -9.22.2015 agents that target IL-1/TNF-alpha. Expires 5.17.2016 9 GASTROINTESTINAL STUDIES –HEPATOCELLULAR – No active trials effective 11/19/2014 STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY 10 GASTROINTESTINAL STUDIES-PANCREATIC STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 0848 A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Ist Randomization Treatment for Patients with Resected Head of Pancreas Adenocarcinoma Arm 1: gemcitabine x 5 cycles Arm 2: gemcitabine + erlotinib x 5 cycles Primary head of pancreas invasive adenocarcinoma resected (i.e., removal of Evaluate to confirm no progression Study Nurse: all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a 2nd Randomization pylorus preserving pancreaticoduodenectomy; IPMN are eligible; T1-3, N0-1, Arm 3: 1 cycle same chemotherapy as first M-0 eligible. randomization treatment arm Arm 4: 1 cycle same chemotherapy as first randomization treatment arm followed by XRT + capecitabine or 5-FU 11 GU PROTOCOL CONTACTS- Bladder, Prostate, Renal RADIATION ONCOLOGY: Investigator – Kenneth L. Zeitzer, MD 215-456-6280 Coordinator – Jeff Mealey, RN 215-456-6316 ECOG/Other: Investigator – William Tester, MD 215-456-3880 Coordinator – Joann Ackler RN, OCN 215-456-8295 12 Prostate STUDY # TITLE and ELIGIBILITY CRITERIA THERAPY RTOG 0534 A PHASE III TRIAL OF SHORT TERM ANDROGEN Arm 1: PBRT alone PBRT 64.8-70.2 Gy DEPRIVATION WITH PELVIC LYMPH NODE OR PROSTATE BED ONLY RADIOTHERAPY (SPPORT) IN PROSTATE Arm 2: PBRT + NC-STAD PBRT 64.8-70.2 Gy + NC-STAD CANCER for 4-6 months, beginning 2 months before RT PATIENTS WITH A RISING PSA AFTER RADICAL PROSTATECTOMY Arm 3: PLNRT + PBRT + NC-STAD PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, Lymph node negative adenocarcinoma of the prostate treated with NC-STAD for 4-6 months, beginning 2 months before RT radical prostatectomy Post-radical prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL; pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin; Gleason ≤ 9 RTOG 0938 A Randomized Phase II Trial Of Hypofractionated Radiotherapy For Treatment techniques/machine Favorable Risk Prostate Cancer-RTOG CCOP Study 1.