Clinical trial · Interventional
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
A Phase I/II Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy
NCT00045110CI-TRIAL-00029117completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Grade III Meningioma | Adult Grade 3 Meningioma | ALIAS | 0.90 |
| Adult Grade II Meningioma | Adult Grade 2 Meningioma | ALIAS | 0.90 |
| Adult Grade I Meningioma | Adult Grade 1 Meningioma | ALIAS | 0.90 |
| Recurrent Adult Brain Tumor |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Escalation
- description
- 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.
- interventionNames
- Drug: erlotinib hydrochloride
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Phase 2 recurrent malignant gliomas and nonprogressive GBM
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 - 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)
* Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
* Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
* Patients found to have dry eyes on examination but have an otherwise normal examination allowed
* No active infection
* No other serious concurrent medical illness
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other disease that would obscure toxicity or dangerously alter drug metabolism
* No significant medical illness that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 12 weeks after study participation
* See Disease Characteristics
* At least 1 week since prior thalidomide
* At least 1 week since prior interferon
* At least 4 weeks since prior SU5416 or other experimental biologic agents
* See Disease Characteristics
* No prior chemotherapy (including polifeprosan 20 with carmustine implant \[Gliadel wafers\]) for patients with stable GBM
* At least 2 weeks since prior vincristine
* At least 3 weeks since prior procarbazine
* At least 6 weeks since prior nitrosoureas
* At least 1 week since prior tamoxifen
* See Disease Characteristics
* Recovered from prior radiotherapy
* No more than 6 weeks since prior external beam radiotherapy for patients with GBM without evidence of progression
* Recovered from prior surgery
* Recovered from prior therapy
* At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except radiosensitizers
* At least 4 weeks since prior cytotoxic therapy
* At least 4 weeks since prior tipifarnib or imatinib mesylate
* No prior erlotinib or other epidermal growth factor receptor inhibitors
* No concurrent combination antiretroviral therapy for HIV-positive patientsReferences
Publications (1)
- BACKGROUNDRaizer JJ, Abrey LE, Lassman AB, Chang SM, Lamborn KR, Kuhn JG, Yung WK, Gilbert MR, Aldape KD, Wen PY, Fine HA, Mehta M, Deangelis LM, Lieberman F, Cloughesy TF, Robins HI, Dancey J, Prados MD; North American Brain Tumor Consortium. A phase I trial of erlotinib in patients with nonprogressive glioblastoma multiforme postradiation therapy, and recurrent malignant gliomas and meningiomas. Neuro Oncol. 2010 Jan;12(1):87-94. doi: 10.1093/neuonc/nop017. Epub 2009 Dec 14. PMID 20150371