Ensuring That No One Has To Face GIST Alone — Newsletter of the Life Raft Group — November 2007 —
November 2007 clinical trial update
By Jim Hughes
LRG Science Team
Phase III continues to enrollpatients at a rapid rate, according to No-vartis. Sites listed in the clinicaltri-als.gov database are open with the fol-lowing exceptions as of October 12: LeeMoffitt in Tampa, FL, MD Anderson inHouston, TX, and New York University,New York, NY. These sites were not yetopen. Over 30 other sites are open out-side the United States, in Canada,Europe, Australia and Taiwan.
Phase I is suspended.
Oblimersen (Genasense) + Imatinib:
Phase II is no longer accruing patients.
Phase I for Advanced SolidTumors is open at the Nevada CancerInstitute in Las Vegas, NV. BEZ235 is aNovartis drug that targets the PI3K tyro-sine kinase and indirectly inhibits thedownstream targets AKT and mTOR.
Imatinib + Pegylated Interferon-a 2B:
This Phase II trial for GIST is a wholedifferent approach. It is primarily forpatients who are newly diagnosed andwho have not had Gleevec (or have beenoff Gleevec for six months or longer).Dr. Lei L. Chen is the primary investiga-tor at the Huntsman Cancer Institute inSalt Lake City, Utah. Dr. Chen theorizesthat Gleevec causes GIST cell deathwhich in turn marks GIST cells for im-mune system response. Interferon willhelp stimulate that response and aid theimmune system in identifying and de-stroying the remaining GIST stem cellsthat can cause relapse after Gleevec hasshrunk tumors. This trial is planned tohave several other innovative aspectsthat are explained in detail in the May2007 Newsletter article “Immunotherapytrial strives to improve Gleevec re-sponse” by Jerry Call, also available onthe LRG website.
Dana-Farber— Travis Quig-ley, RN, Research Nurse, has indicatedthat both the Sorafenib (BAY 43-9006)Phase II and the Phase III Sunitinib orImatinib trial are available there.
Safety and effectiveness of daily dosing withsunitinib or imatinib in GIST patients
Phase:Conditions:Strategy:NCT#:US Contact:Telephone:Sites:IIIGISTMultiple TargetsNCT00372567
Pfizer Clinical Trial Informationpfizercancertrials@emergingmed.com
, Boston, MATravis Quigley, RN, 617-632-5117IIGISTMultiple TargetsNCT00455559
Online Collaborative Oncology Group
Cancer Center at Century City,
Los Angeles, CASant Chawla, MD
Coeur D’Alene, ID
, Park Ridge, ILKathy Tolzein, RN, 847-268-8200Grand Rapids, MI
, Houston, TX800-392-1611
Phase II study of Perifosine plus Gleevec for GIST patients
Efficacy and safety of AMN107 compared tocurrent treatment options in GIST patientswho failed imatinib and sunitinib
IIIGISTInihibit KITNCT00471328Novartis800-340-6843, Trial# CAM-N107A2201
, Los Angeles, CAMyung Lee, 310-825-4494
Wash. Cancer Inst.
, Wash. DCJake Paterson, 202-877-5371
Univ. of Chicago
, Chicago, ILPatient Coordinator:773-834-7424
, Boston, MATravis Quigley, RN, 617-632-5117
Karmanos Cancer Institute.
, De-troit, MIAnne Marie Ferris, 313-576-9373
., St. Louis, MONick Fisher, 314-354-5102
, Winston-Salem, NCScarlet Hutchins, RN, 336-713-6915
, Philadelphia, PA1-800-FOX-CHASEPhase:Conditions:Strategy:NCT#:US Contact:Telephone:Sites:
Imatinib +Pegylated Interferon-a 2B
Combines targeted therapy with immunother-apy using Imatinib + Pegylated Interferon-a2B in imatinib-naïve GIST patient
IIGISTKill GIST cellsHCI 22172
Huntsman Cancer Institute
Candace, 801-581-4477Phase:Conditions:Strategy:Study #:US Contact:
(BAY 43-9006, Nexavar®)
Sorafenib in treating patients with malignant GIST that progressed during or after treat-ment with imatinib and sunitinib
Phase:Conditions:Strategy:NCT#:US Contact:Telephone:Sites:IIGISTMultiple TargetsNCT00265798
Univ. Of Chicago Cancer Re-search Center
, Chicago, IL773-834-7424
City of Hope,
Duarte, CAWarren Chow, MD, 866-434-4673xt 64215
Cancer Care Specialists,
Decatur,ILJames Wade III, MD, 217-876-6617
Oncol./Hematology Assoc. of Cent
, Peoria, ILJohn Kugler, MD, 309-243-3605
, Boston, MATravis Quigley, RN: 617-632-5117
NewYork, NYDavid D’Adamo, MD, 212-639-7573
In last month’s newsletter we reportedthat 2 patients who were resistant toGleevec and other drugs appeared to beresponding to Nexavar. We have subse-quently learned that the patient withsymptomatic improvement, that wasable to leave hospice, demonstrated pro-gression upon further examination.
Up to the minute...
See TRIALS, Page 9