The Clinical Research E-News

Transcription

1 The Clinical Research E-News Volume 7: ISSUE 2: February 19, 2015 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: New Featured Trials Actively Recruiting at the Sidney Kimmel Cancer Center at Jefferson University: 1. Title: An Exploratory Study to Investigate the Immunomodulatory Activity of Radiation Therapy (RT) in Combination with MK-3475 in Patients with Recurrent/Metastatic Head and Neck Cancer, Renal Cell Cancer, Melanoma and Non-Small Cell Lung Cancer a. Principal Investigator: Jianqing Lin, MD b. Primary Objective: To investigate the immunomodulatory activity of radiation therapy (RT) or RT in combination with anti-pd-1 antibody (MK-3475) in patients with recurrent/metastatic head and neck cancer, renal cell cancer, melanoma and nonsmall cell lung cancer c. Eligibility: Recurrent/metastatic head and neck cancer, renal cell cancer, melanoma and non-small cell lung cancer. Have provided tissue from an archival tissue sample (< 6 months old) or newly obtained core biopsy of a tumor lesion before radiation therapy. A core biopsy will be required. It is mandatory to have post-radiation rebiopsy. In addition to index lesion, there are 1 measurable lesion(s). d. Treatment: e. Contact: The CRMO office at

2 2. Title: A Phase Ib/II Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma a. Principal Investigator: Onder Alpdogan, MD b. Eligibility: Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens. Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy and progressive disease is defined by a 25% increase from the lowest response value in specified tests. Measurable disease as defined by at least one of the following: serum M-protein 1g/dL (for IgG, IgM) or 0.5 g/dl (for IgA), urine M- protein 200mg/24hours, serum free light chains 10 mg/dl and abnormal kappa/lambda ratio. No anti-myeloma treatments within 28 days before the start of study treatment. c. Treatment: Biological: ALT-803 intravenous infusion; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles d. Contact: Briana Shields at Pager or briana.shields@jefferson.edu Open to Accrual A011202, A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (ct1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy Pending Studies for Network Participation: EA2212, A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver N0577, Phase III Intergroup Study of Temozolomide Alone Versus Radiotherapy with Concomitant and Adjuvant Temozolomide Versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma NRG-BR001, Phase I Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NRG-LU001, Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC S1406, Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

3 Please contact Rashada Dawson at or if your site is interested in participating in any of these trials. Regulatory Update: E2408- Addendum #11 E2511- Amendment #5 E5103- Addendum #13 E1305- Study Closure R1008- Amendment #7 R0837- Addendum #7 E1508- Update #3 B-47- Study Closure Z1071- Update #1 R0615- Amendment #5 Please contact Rashada Dawson for any regulatory update inquiries. Regulatory Update Jefferson Conflict of Interest-SMART: - We are excited to announce that Jefferson University s Committee on Conflicts of Interest and Commitment will launch a new Conflicts of Interest disclosure system. Jeff-COI-SMART is a web-based application that enables users to quickly and conveniently submit Jefferson's required Financial Conflicts of Interest Disclosure Forms. Jeff-COI-SMART maintains electronic copies of all Conflict of Interest submissions and for your convenience will auto-populate previously submitted information to minimize the need for re-entry year after year. Most importantly, Jeff-COI-SMART's system controls ensure that the information you disclose is maintained securely and privately. The new Jeff-COI-SMART system provides a real-time, user friendly way to manage the emerging complexities associated with Jefferson s rapid growth in research and innovation. Our team of Conflicts of Interest experts will use the Jeff-COI-SMART system to support the advancement of innovation while protecting the integrity of Jefferson s processes and activities. The first phase of the Jeff-COI- SMART system will be rolled out to the TJU employees immediately with a second phase for non-tju employees coming sometime this summer. Jefferson Investigators Can Now Use Western IRB (WIRB) for Facilitated Review of Multicenter Trials: The Office of Human Research is pleased to announce the launch of the Western IRB (WIRB) application process. This will allow investigators to apply to WIRB to join existing or pending studies. The application process is limited to select phase 2, 3 & 4 multicenter studies that are commercially funded. All final decisions on whether or not an investigator is permitted to apply to join a study will be made by the Office of Human Research. We hope this new service will afford Jefferson investigators the opportunity to join studies they otherwise would not know about or be involved with and to be able to start enrolling at the same time as other sites included under the initial WIRB approval.

4 Please contact Joshua Schoppe at or for any Regulatory inquiries. ECOG-ACRIN Update ECOG-ACRIN Stickers: Effective immediately, ECOG-ACRIN will no longer be mailing patient registration materials to our institutions. Confirmations of registration and eligibility checklists can be printed though OPEN for all active studies. If you wish to receive patient labels, all requests must be ed to The following information must be contained in the in order for you to receive your request promptly: protocol number, patient number and step number (if no step number is provided, step 1 labels will be mailed by default), name and mailing address to which labels should be sent. Please note that telephone and fax requests are no longer being accepted. Important Follow-Up Information ECOG-ACRIN PCO Move: As of December 31st the former ECOG Pathology Coordinating Office (PCO) located at Northwestern University in Chicago has CLOSED and there is no longer dedicated staff at the PCO to receive and forward misrouted packages. Any packages sent to the PCO will be returned to the shipper. All specimens originally intended for shipment to the PCO must be shipped to the new ECOG- ACRIN Central Biorepository and Pathology Facility (EA CBPF). This message must be relayed to all staff responsible for shipping ECOG-ACRIN study related specimens. It is very important for the integrity of the specimens to ensure that shipment information is correct. For sites using the CBPF provided FedEx ship manager, please update the profile settings of the account to make the CBPF your shipping destination default with the following address: NEW ADDRESS: ECOG-ACRIN Central Biorepository and Pathology Facility MD Anderson Cancer Center Department of Pathology, Unit 085 Tissue Qualification Laboratory for ECOG-ACRIN, Room G Holcombe Boulevard Houston, TX Toll Free Phone: (844) ( Local or International Sites) Fax: (713) eacbpf@mdanderson.org Shipments to other banks or investigating laboratories are unaffected by the PCO-EA CBPF move. The ECOG-ACRIN Sample Tracking System has been updated with the new address. A large number of protocols have been updated, with the remainder having updates in the approval

5 process, to reflect this change. Please file this memo with any protocols not yet amended as documentation of the change. Please contact the ECOG-ACRIN Translational Science Team at or (617) with any questions. ECOG-ACRIN Performance Monitoring: Thank you to all of your hard work! We received this message from the ECOG-ACRIN Data Management Team: The Performance Monitoring run was done on February 11, This run was based on clinical data received on or before December 31, Congratulations to your network for submitting the required CRFs and survival follow-up data! Your network was over the 90% mark. The next data cutoff date is March 31, Please contact Joshua Schoppe for any ECOG-ACRIN update inquiries. NRG Update UPCOMING NRG AUDIT REMINDER: The upcoming NRG audit for TJU and its affiliates is anticipated for early June The audit will include Regulatory, Pharmacy and subject cases for Main member and all affiliates. The subject cases will include 10% of NCTN, 10%DCP, and/or 10% of all 3 legacy groups. If, for example, a SWOG, ECOG, Alliance, etc. trial gives credit to NRG these trials may be reviewed as well. The Lead RA will be contacted 6 weeks prior to the audit with the audit date; 2-4 weeks for the cases being reviewed; 0-1 day for surprise case. More details to follow. NSABP-B47, 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, closed to accrual on Tuesday, February 10, Please continue to submit all due data as indicated per the protocol. Please contact Cynthia Perez at or Cynthia.Perez@jefferson.edu with any related NRG issues. Upcoming Events: Lung Cancer Symposium: Jefferson Campus, March 6th CRA Meeting: Virtual Meeting, March 26 th SKCN Social Workers Meeting: Jefferson Campus, March 13 th SKCC Annual Symposium, Upper GI Malignancies: Hyatt Penn s Landing, April 17 th

6 SKCN Administrators Meeting: Jefferson Campus, April 24 th ECOG-ACRIN Meeting: Chicago, IL, April 30 th to May 2 nd SKCN Navigators Meeting: Jefferson Campus, May 5 th CRA Meeting: Jefferson Campus, June 17th CRA Meeting: Virtual Meeting, September 30th CRA Meeting: Jefferson Campus, December 16th The Clinical Research E-News Archive is now located on the Sidney Kimmel Cancer Center webpage under the JKCCN Member Area: Please provide feedback and any suggestions to Joshua Schoppe. Sidney Kimmel Cancer Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository.