The Clinical Research E-News

Transcription

1 Volume 2: ISSUE 11: June 2, 2010 The Clinical Research E-News SPECIAL ALERT: The quarterly CRA Meeting will be held at 8:30am on June 16, 2010 at the Bluemle Science Building room 105. Now Open: SWOG0777, A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC ) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC ), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant. RTOG0627, Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme ECOG 3805,CHAARTED - Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer Coming soon: NSABP P-5, Statin Polyp Prevention Trial in Patients with Resected Colon Cancer 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 RTOG0920, A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer.

2 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) RTOG 0915, Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients with Stage I Peripheral Non-Small Cell Lung Cancer ECOG 1697, Phase III Randomized Study of Four Weeks High Dose IFN-A2B in Stage T2B NO, T3A-B NO, T4A-B NO, and T1-4, N1A, 2A, 3 (microscopic) Melanoma CALGB10403, An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL) If your site is interested in participating in any of these studies please contact Rolma Gano at or Rolma.gano@jeffersonhospital.org. Regulatory Update: The following studies have had recent consent form changes or updated letters posted on the repository website: ECOG 2607 BETH NSABP B-43 GOG 258 NASBP R-04 SWOG 0500 GOG 249 RTOG 0534 ECOG 4508 CALGB START ECOG 3805 (CHAARTED) SWOG 0777

3 If any of these studies pertain to your site please visit the repository at: Please contact Rolma Gano with any repository or other regulatory related questions. Quality Assurance Update: Please contact Kelly Shipman with any QA related issues at or CTSU Update: CIRB Record Keeping for Audits: A memorandum from the CIRB dated April 1, 2010 entitled "Change in CIRB Review Process of Adverse Event Reports for Phase III Clinical Trials" stated, Effective immediately, the adult and pediatric CIRBs will no longer review individual adverse event reports related to Phase 3 CTEP-sponsored multicenter trials that are submitted by Cooperative Groups to the CIRBs and investigators. Pursuant to this change, CTSU will no longer expect to see CIRB documentation downloaded from the CIRB website regarding submission of external adverse events or Safety Reports. This was previously required in lieu of a local institution policy on maintaining regulatory files for CIRB approved studies. ECOG Update: E1305, A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer, is struggling to meet its accrual goal. This important trial for patients with recurrent or metastatic head and neck cancer randomizes patients between cisplatin-based chemotherapy with or without bevacizumab, a drug for which we have good phase I and II data in head and neck cancer. The purpose of the trial is to determine if the use of bevacizumab combined with two different chemotherapy regimens will improve overall survival. This study offers the real possibility of increasing standard treatment options for patients with head and neck cancer, and gives our patients potential access to a novel treatment

4 now. A variety of educational tools are being created to provide investigators, clinical research staff, patient advocates and patients with the information they need to increase protocol awareness. Print material will be available by the June 2010 ECOG Group meeting. E1508, A Randomized Phase II Study of Cisplatin and Etoposide in Combination with Either HedgeHog (HH) Inhibitor GDC-0449 or IGF-1R MoAB(IMC-A12) for Patients with Extensive Stage Small Cell Lung Cancer (SCLC), is currently SUSPENDED until Addendum #4 is approved by the TJUH IRB. The addendum updates the risk profile of IMC-A12. E4508, Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination with Cetuximab, IMC-A12 or Both for Advanced Non-small Cell Lung Cancer Patients Who Will Not Receive Bevacizumab-based Therapy is currently RE-OPENED with the TJUH IRB approval of Addendum #2. The addendum updates the risk profile of IMC-A12. E2607, A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas, is open to accrual to all ECOG members. If your site is interested in participating please contact Josh Schoppe at your earliest convenience. ECOG Spring Meeting: The ECOG spring meeting will be held at the JW Marriott Hotel in Washington, D.C., June 11 th through the 13 th. Meeting registration will be done online again for this meeting. To register for the Group Meeting, please use the link below. Please note that the schedule is updated on an ongoing basis. The schedule provided is for current reference only and is subject to change at any time. ECOG strongly recommends that all meeting attendees check the most current schedule online before making travel arrangements, as ECOG will not be responsible for ticket change fees due to scheduling changes.

5 Performance Monitoring: The next Performance Monitoring data cut-off date of June 30, 2010 is approaching. Any data received on or before June 30, 2010 will be included in the upcoming Performance Monitoring. Data received after June 30, 2010 will be considered late. It is important to remember that data timeliness will be evaluated by assessing two components: The rate of CRF submitted and the rate of survival follow-up. To avoid penalties, each evaluable ECOG institution must have a score of 90% or better on each component. If you have an ECOG related question please contact Joshua Schoppe. NSABP Update: NSABP R-04, as of May 26, 2010, a total of 1552 (96.6%) patients have been accrued. Accrual is projected to be completed in late August of Please continue to screen and consent patients for the trial. We will provide an update when a definite closure date is determined. NSABP P-5, Statin Polyp Prevention Trial in Patients with Resected Colon Cancer, will soon be open to accrual at TJUH and available to our cancer network affiliates. Although P-5 is a prevention trial, accrual will be counted in the interventional or treatment category. The accrual goal is 1,740. Scott Goldstein, MD, is serving as principal investigator. The primary aim of the trial is to determine if the administration of 5 years of postoperative rosuvastatin affects the 5-year occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma and colon cancer recurrence in patients with resected colon cancer. If you have an NSABP related question please contact Vicki Squire at vicki.squire@jeffersonhospital.org or at

6 RTOG Update: On June 23, 2010 RTOG will begin using the CTSU OPEN registration system for patient enrollment to RTOG The RTOG web registration system for RTOG 0436 will no longer be available and when accessed will direct you to the OPEN registration link. Other studies are currently being assessed and will be added to the CTSU OPEN registration system shortly. RTOG will announce each study prior to implementation. New versions of the RTOG 0436 and RTOG 0539 newsletters are posted on the RTOG website at and The next RTOG Semiannual meeting will be held June 17-20, 2010, at the Loews Philadelphia Hotel in Philadelphia, PA. General information about the meeting can be found at Please preregister via the following link: Jefferson Oncology Group (JOG) Update: If your site has any JOG inquires please contact either Josh Schoppe or Vicki Squire. Jefferson Kimmel Cancer Center Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository. Upcoming Events: ECOG Spring Meeting, Washington, D.C.: June JKCCN CRA Meeting, Philadelphia PA: June 16 Otolaryngology Grand Rounds, Philadelphia, PA: 5:30pm, June 16 FDG PET/CT in Head and Neck Cancer

7 RTOG Semiannual Meeting, Philadelphia, PA: June The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: Please provide feedback and any suggestions to Joshua Schoppe at or