Sorafenib Combined With Erlotinib, Tipifarnib, or Temsirolimus in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00335764
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sorafenib tosylate — DRUG
    given orally
  • erlotinib hydrochloride — DRUG
    given orally
  • tipifarnib — DRUG
    given orally
  • temsirolimus — DRUG
    IV administration

Study Details

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. 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.

Key Dates

First listed
Jun 12, 2006
Start date
Apr 30, 2006
Status verified
May 2018
Primary completion
Feb 28, 2010
Completion
Sep 30, 2012

Study Design

Enrollment
92 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Patients receive oral sorafenib tosylate twice daily and oral erlotinib hydrochloride once daily on days 1-28.
  • Experimental: Group 2
    Patients receive sorafenib tosylate as in group 1. Patients also receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • Experimental: Group 3
    Patients receive sorafenib tosylate as in group 1. Patients also receive oral tipifarnib twice daily on days 1-21.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of the Each Combination Agent Combined With a Fixed Dose of BAY 43-9006 Determined by Dose-limiting Toxicities (DLT) (Phase I) [ Time Frame: 28 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia90095-
University of California San FranciscoSan FranciscoCalifornia94115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
University of PittsburghPittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By research site
University of California at Los Angeles· Los Angeles, CAUniversity of California San Francisco· San Francisco, CADana-Farber Cancer Institute· Boston, MAMemorial Sloan-Kettering Cancer Center· New York, NYUniversity of Pittsburgh· Pittsburgh, PAM D Anderson Cancer Center· Houston, TX

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