Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00112736
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Diffuse Astrocytoma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Adult Pilocytic Astrocytoma
  • Adult Pineal Gland Astrocytoma
  • Adult Subependymal Giant Cell Astrocytoma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • erlotinib — DRUG
    Given orally
  • temsirolimus — DRUG
    Given IV
  • therapeutic conventional surgery — PROCEDURE
    Undergo surgical resection
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

Erlotinib and temsirolimus and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with erlotinib and to see how well they work in treating patients with recurrent malignant glioma.

Key Dates

First listed
Jun 3, 2005
Start date
Apr 30, 2005
Status verified
May 2015
Primary completion
Apr 30, 2010
Completion
Apr 30, 2014

Study Design

Enrollment
69 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (erlotinib & temsirolimus)
    PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity. pharmacological study: Correlative studies
  • Experimental: Phase 2 temsirolimus MTD & erlotinib
    Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I. therapeutic conventional surgery: Undergo surgical resection laboratory biomarker analysis: Correlative studies

Primary Outcome Measure

Efficacy - Response Phase 1 [ Time Frame: at least 8 weeks of treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
University of California San FranciscoSan FranciscoCalifornia94115-
National Cancer Institute Neuro-Oncology BranchBethesdaMaryland20814-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
University of PittsburghPittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-
University of Texas Health Science CenterSan AntonioTexas78229-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CAUniversity of California San Francisco· San Francisco, CANational Cancer Institute Neuro-Oncology Branch· Bethesda, MDDana-Farber Cancer Institute· Boston, MAUniversity of Pittsburgh· Pittsburgh, PAM D Anderson Cancer Center· Houston, TX

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