The Clinical Research E-News
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1 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
2 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 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 or Joshua.Schoppe@jeffersonhospital.org
3 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, 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 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 This
4 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 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 The meeting will be held in San Diego, January 13-16, The meeting agenda and brochure can be found on the RTOG website at Please contact Joshua Schoppe or Vicki Squire with any RTOG related issues.
5 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: 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 CRA Quarterly Meeting, Philadelphia, PA: March 9th NSABP Semiannual Meeting, Boca Raton, FL: March JKCCN All Day Annual Scientific and Clinical Symposium Topic: Breast Cancer: Philadelphia, PA: April 11th ECOG Semiannual Meeting, Boston, MA: 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
The Clinical Research E-News
Volume 3: ISSUE 2: January 26, 2011 The Clinical Research E-News Now Open: E2208, Randomized Phase II Study of Paclitaxel With or Without the Anti- IGF-IR mab Cixutumumab (IMC-A12) as Second Line Treatment
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Volume 3: ISSUE 3: February 16, 2011 The Clinical Research E-News Now Open: RTOG 0631, Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis RTOG 1010, A Phase III Trial Evaluating
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Volume 3: ISSUE 4: March 2, 2011 The Clinical Research E-News Now Open: E1608, A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients with Advanced Melanoma E2208, Randomized Phase II Study of
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The Clinical Research E-News Volume 2: ISSUE 19: October 13, 2010 Coming soon: RTOG 0929, A Randomized, Phase I/II Study of ABT-888 in Combination with Temozolomide in Recurrent (Temozolomide Resistant)
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Volume 3: ISSUE 9: May 18, 2011 The Clinical Research E-News Jefferson Kimmel Cancer Network: For urgent clinical trial questions or assistance please page: 877-656-9004 Now Open: RTOG 0837, A Randomized,
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Volume 3: ISSUE 5: March 23, 2011 The Clinical Research E-News Now Open: CALGB 90802, Randomized Phase III trial comparing everolimus plus placebo versus everolimus plus bevacizumab for advanced renal
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Volume 3: ISSUE 8: May 5, 2011 The Clinical Research E-News Jefferson Kimmel Cancer Network: For urgent clinical trial questions or assistance please page: 877-656-9004 Now Open: E2906, Phase III randomized
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Volume 2: ISSUE 5: March 10, 2010 The Clinical Research E-News Coming soon: AZ1071, A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative
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Volume 3: ISSUE 11: June 15, 2011 The Clinical Research E-News Reminder: CRA Quarterly Meeting, Philadelphia, PA: 10-11am on Wednesday June 22nd- Virtual Meeting: dial information attached in a separate
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Volume 2: ISSUE 6: March 24, 2010 The Clinical Research E-News SPECIAL ALERT: The annual JOG investigator Meeting will be held at 5pm on May 10, 2010 at the Loews Hotel. Now Open: AZ1071, A Phase II Study
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Volume 2: ISSUE 8: April 21, 2010 The Clinical Research E-News SPECIAL ALERT: The annual JOG investigator Meeting will be held at 5:30pm on May 10, 2010 at the Loews Hotel. Coming soon: NSABP FC-6, A Phase
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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,
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Volume 2: ISSUE 7: April 7, 2010 The Clinical Research E-News SPECIAL ALERT: The annual JOG investigator Meeting will be held at 5pm on May 10, 2010 at the Loews Hotel. Now Open: RTOG0831, A Randomized,
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Volume 2: ISSUE 10: May 19, 2010 The Clinical Research E-News Coming soon: NSABP FC-6, A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mfolfox7 Plus Cetuximab
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The Clinical Research E-News Volume 3: ISSUE 16: September 28, 2011 Jefferson Kimmel Cancer Network: For urgent clinical trial questions or assistance please page: 877-656-9004 Now Open: C70604, A Randomized,
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ISSUE 18: September 9, 2009 New Activations: The Clinical Research E-News SWOG0518, Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab
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Volume 4: ISSUE 6: August 28, 2012 The Clinical Research E-News Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Trials Opened at
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The Clinical Research E-News Volume 7: ISSUE 1: January 16, 2015 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Featured Trials
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ISSUE 10: May 20, 2009 The Clinical Research E-News New Activations at TJU: No new activations. Regulatory Update: The following studies have had recent consent form changes posted on the repository website:
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The Clinical Research E-News Volume 6: ISSUE 5: June 12, 2014 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Featured Trials Actively
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The Clinical Research E-News Volume 6: ISSUE 5: May 14, 2014 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Featured Trials Actively
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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: 877-656-9004 New Featured Trials
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The Clinical Research E-News Volume 6: ISSUE 11: November 19, 2014 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Featured JOG Trial
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