Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
Completed · Phase 1/Phase 2
Conditions studied: 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
In brief
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 facts
- Study ID
- NCT00045110
- Run by
- National Cancer Institute (NCI)
- People needed
- 136
- Starts
- 2002-08-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2017-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 - Karnofsky 60-100%
- More than 8 weeks
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 10 mg/dL (transfusion allowed)
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT less than 1.5 times ULN
- Creatinine less than 1.5 mg/dL
- None of the following ophthalmic abnormalities:
- Abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
- Congenital abnormality (e.g., Fuch's dystrophy)
Where it is running
- University of California Los Angeles — Los Angeles, California, United States
- University of California San Francisco — San Francisco, California, United States
- National Cancer Institute Neuro-Oncology Branch — Bethesda, Maryland, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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