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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00335764 |
Purpose
RATIONALE: Sorafenib, erlotinib, tipifarnib, and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib, tipifarnib, or temsirolimus may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib, and temsirolimus when given together with sorafenib and to see how well they work in treating patients with recurrent glioblastoma multiforme or gliosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: erlotinib hydrochloride Drug: sorafenib tosylate Drug: temsirolimus Drug: tipifarnib |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Studies of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib), R115777 (Tipifarnib) or CCI-779 (Temsirolimus) in Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma |
| Estimated Enrollment: | 183 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Patients receive oral sorafenib twice daily and oral erlotinib hydrochloride once daily on days 1-28.
|
Drug: erlotinib hydrochloride
Given orally
Drug: sorafenib tosylate
Given orally
|
|
Experimental: Group 2
Patients receive sorafenib as in group 1. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
|
Drug: sorafenib tosylate
Given orally
Drug: temsirolimus
Given IV
|
|
Experimental: Group 3
Patients receive sorafenib as in group 1. Patients also receive oral tipifarnib twice daily on days 1-21.
|
Drug: sorafenib tosylate
Given orally
Drug: tipifarnib
Given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Evidence of tumor progression by MRI or CT scan within the past 14 days AND on a steroid dose that has been stable for ≥ 5 days
Recent resection of recurrent or progressive tumor allowed
No more than 3 prior therapies (initial therapy and therapy for 2 relapses) (phase II)
Each of the following is considered 1 relapse:
PATIENT CHARACTERISTICS:
PT/INR ≤ 1.5 (INR < 3.0 for patients on anticoagulation therapy)
PRIOR CONCURRENT THERAPY:
No other concurrent CYP3A4 inducers (e.g., rifampin or Hypericum perforatum [St. John's wort])
Full-dose anticoagulants allowed provided both of the following criteria are met:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-6220 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Study Chair: | Mark R. Gilbert, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Director, ABTC, Adult Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00335764 History of Changes |
| Other Study ID Numbers: | CDR0000476286, U01CA062399, ABTC-05-02, NABTC-05-02 |
| Study First Received: | June 8, 2006 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma recurrent adult brain tumor |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Sirolimus Everolimus Tipifarnib Sorafenib Erlotinib Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |