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 range
18 Years
Sex
ALL
See this in plain English?
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 - Karno…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)