Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Mening⦠(NCT00045110) | Clinical Trial Compass
CompletedPhase 1/2
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
United States136 participantsStarted 2002-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* One of the following diagnoses:
* Histologically confirmed intracranial malignant glioma
* Glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
* Original histology of low-grade glioma allowed provided a subsequent histology of malignant glioma is confirmed
* Histologically or radiographically confirmed recurrent or progressive benign or malignant meningioma
* Progressive disease or tumor recurrence on MRI or CT scan
* Phase I: No more than 3 prior relapses and no more than 2 prior chemotherapy\* or biologic therapy regimens
* Phase II: No more than 2 prior relapses and no more than 2 prior chemotherapy\* or biologic therapy regimens
* Patients with progressive disease must have failed prior radiotherapy\* that was completed at least 4 weeks ago
* Patients with progressive disease between 4 and 12 weeks after completion of external beam radiotherapy must have clear evidence of progression on MRI
* Patients with GBM who have completed external beam radiotherapy and do not show progression are eligible
* Patients with progressive disease after interstitial brachytherapy or stereotactic radiosurgery must have confirmed true progression rather than radiation necrosis based upon positron-emission tomography, thallium scanning, MRI, or surgical documentation
* Measurable or evaluable disease
* Performance status - Karnoā¦
What they're measuring
1
Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I
Timeframe: 28 days
2
Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts
Timeframe: cycle 1 - 28 days
3
6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II)