Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00045110
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Grade I Meningioma
  • Adult Grade II Meningioma
  • Adult Grade III Meningioma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    given orally
  • laboratory biomarker analysis — OTHER
    correlative studies
  • pharmacological study — OTHER
    correlative studies

Study Details

Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Key Dates

First listed
Jan 27, 2003
Start date
Aug 31, 2002
Status verified
Jul 2017
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

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

Arms

  • Experimental: Phase 1 Dose Escalation
    Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study.
  • Experimental: Phase 2 recurrent malignant gliomas and nonprogressive GBM
    Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose (150mg/day. patients requiring surgery treated 7 days prior to tumor removal (150mg/day) PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis.

Primary Outcome Measure

Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I [ Time Frame: 28 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
University of California San FranciscoSan FranciscoCalifornia94115-
National Cancer Institute Neuro-Oncology BranchBethesdaMaryland20814-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of PittsburghPittsburghPennsylvania15232-
University of Texas Southwestern Medical CenterDallasTexas75235-
University of WisconsinMadisonWisconsin53792-

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, MDMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Pittsburgh· Pittsburgh, PAUniversity of Texas Southwestern Medical Center· Dallas, TX

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