The Clinical Research E-News Volume 2: ISSUE 23: December 16, 2010 Coming soon: E1608, A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients with Advanced Melanoma E2208, Randomized Phase II Study of Paclitaxel With or Without the Anti- IGF-IR mab Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer E2408, A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma NSABP C-11, A Phase III Study Evaluating the Role of Preoperative Chemotherapy and Bevacizumab in Patients with Potentially Resectable Hepatic Colorectal Metastases RTOG 0631, Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis RTOG0912, A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib/Placebo, for the Treatment of Anaplastic Thyroid Cancer RTOG 0929, A Randomized, Phase I/II Study of ABT-888 in Combination with Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma
RTOG 1008, A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors RTOG 1014, A Phase II Study of Repeat Breast Preserving Surgery and 3D- Conformal Partial Breast Irradiation (PBRI) for Local Recurrence of Breast Carcinoma If your site is interested in participating in any of these studies please contact Rolma Gano at 215-955-7954 or Rolma.gano@jeffersonhospital.org. Regulatory Update: E1505 R0825 amendment #3- reconsent C90203 C40502 Update #3 E1305 carboplatin letter Please contact Rolma Gano with any repository or other regulatory related questions. CTSU Update: 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), is undergoing a revision to add ANC and platelet requirements for Day 1 of each cycle. This language was inadvertently deleted from the protocol. The protocol revision that incorporates this change will be forthcoming from SWOG. However, institutions should begin to apply these hematologic requirements immediately. Please contact Joshua Schoppe with any CTSU related issues at 215-955-0448 or Joshua.Schoppe@jeffersonhospital.org
ECOG Update: E2804, The BEST Trial: A Randomized Phase II Study of VEGF, RAF kinase and mtor Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma closed to accrual on December 10, 2010. Patients currently on this study should be followed according to the protocol. Sample submissions should continue during the follow-up period as specified in the protocol. The ECOG Coordinating Center will be closed on Friday, December 24, and Friday, December 31. The ECOG Pathology Coordinating Office (PCO) will be closed on Friday, December 24th, Monday, December 27th, Thursday, December 30th and Friday, December 31st, but will have skeleton crews available. Ambient specimens must get shipped the day of collection. Frozen specimens must get shipped out by Wednesday, December 22nd or Tuesday, December 28th, if unable to ship out then hold off until Tuesday, December 28th or Monday, January 3rd, accordingly. Do not ship specimens on Friday, December 24th or 31st. If you have an ECOG related question please contact Joshua Schoppe. NSABP Update: C-08 Memo: Please link to an important memo posted on the NSABP website regarding follow up for C-08. https://members.nsabp.pitt.edu/c08_followup_status_clarification_120210.p df BETH Trial: Registration for the BETH Trial ended 9/24/10 and notification of the end of randomization was received on 12/13/10. The last patient was randomized on 12/10/10, bringing the final number randomized to 3509. This
international trial completed accrual 5 months earlier than initially planned. Thank you to our cancer network members who participated. Please check the NSABP website for memos regarding holiday hours, drug ordering and scheduling of chemotherapy over the holidays. NSABP has announced their next group meeting. It is scheduled for March 24-27, 2011 in Boca Raton, FL. Meeting and travel information will be sent mid-january. If you have an NSABP related question please contact Vicki Squire at vicki.squire@jeffersonhospital.org or at 215-503-5641. RTOG Update: RTOG Biospecimen Resource Holiday Schedule: The RTOG Biospecimen Resource will be closed for the upcoming Holidays: Friday December 24th and Monday December 27 th and Thursday December 30th -Friday December 31 st. Frozen Biospecimens: To avoid possible delays due to winter weather conditions or customs we ask that sites do NOT ship any frozen biospecimens to us after TUESDAY December 21st, (Monday the 20th for Canadian sites) but instead wait to ship on Monday January 3rd. Registration for the RTOG Semiannual Meeting is now available at https://registrations.acr.org/rtog. The meeting will be held in San Diego, January 13-16, 2011. The meeting agenda and brochure can be found on the RTOG website at http://www.rtog.org/meeting/main.html. Please contact Joshua Schoppe or Vicki Squire with any RTOG related issues.
Jefferson Oncology Group (JOG) Update: If your site has any JOG inquiries please contact either Joshua Schoppe or Vicki Squire. Jefferson Kimmel Cancer Center Network Homepage: http://www.kimmelcancercenter.org/jkccn/. This page contains links to the Remote Access Portal as well as the clinical trial document repository. Upcoming Events: RTOG Semiannual Meeting, San Diego, CA: January 13-16 CRA Quarterly Meeting, Philadelphia, PA: March 9th NSABP Semiannual Meeting, Boca Raton, FL: March 24-27 JKCCN All Day Annual Scientific and Clinical Symposium Topic: Breast Cancer: Philadelphia, PA: April 11th ECOG Semiannual Meeting, Boston, MA: June 10-12 The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: http://www.kimmelcancercenter.org/jkccn/e-newsletters.html Please provide feedback and any suggestions to Joshua Schoppe at 215-955- 0448 or email Joshua.schoppe@jeffersonhospital.org