Conditions

Keywords

recurrent adult brain tumoradult meningiomaadult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult pilocytic astrocytomaadult subependymomaadult mixed gliomaadult meningeal hemangiopericytomaadult grade III meningiomaadult giant cell glioblastomaadult gliosarcomaadult grade I meningiomaadult grade II meningioma

Outcome Measures

Primary Outcomes (1)

Progression-free survival at 6 months
6 months

Study Arms (2)

p450

ACTIVE COMPARATOR

p450 inhibitor

Drug: gefitinib

nonp450

ACTIVE COMPARATOR

not on p450 inhibitor

Drug: gefitinib

Interventions

gefitinibDrug

nonp450p450

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Histologically confirmed supratentorial malignant primary glioma * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Histologically confirmed or radiographically defined recurrent or progressive brain or spinal meningioma, including base of skull or cavernous sinus meningiomas * Benign, malignant, or atypical * May include neurofibromatosis type I or II * Hemangiopericytoma allowed * Recurrent or progressive disease by MRI or CT scan * Evidence of true progressive disease by PET or thallium scan, MR spectroscopy, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery (to the target lesion for meningioma and hemangiopericytoma) * Steroid dosage must be stable for at least 5 days prior to scan * No limitations on the number of prior surgeries, radiotherapy or chemotherapy regimens, or radiosurgery treatments for patients with meningioma or hemangiopericytoma and may include standard external beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery in any combination * Patients with glioma must have failed prior radiotherapy * Original histology of low-grade glioma allowed if subsequent confirmation of malignant glioma is made at time of recurrence * Phase I (closed to accrual as of 09/19/2003): * Prior treatment for no more than 3 prior relapses in patients with glioma * Phase II: * Measurable disease after prior surgical resection of recurrent or progressive disease * Prior treatment for no more than 2 prior relapses in patients with glioma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 120,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT less than 1.5 times ULN Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No significant cardiac risk factors within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months * No active infection * No concurrent disease that would obscure toxicity or dangerously alter drug metabolism * No other significant medical illness that would preclude study * No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon or thalidomide * No concurrent filgrastim (G-CSF) Chemotherapy: * See Disease Characteristics * At least 2 weeks since prior vincristine * At least 6 weeks since prior nitrosoureas * At least 3 weeks since prior procarbazine Endocrine therapy: * At least 1 week since prior tamoxifen Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics * At least 7 days since prior surgery for recurrent or progressive tumor and recovered Other: * Recovered from prior therapy * No prior gefitinib or other epidermal growth factor receptor inhibitor * At least 1 week since prior isotretinoin * At least 1 week since other prior noncytotoxic agents (except radiosensitizers) * At least 4 weeks since prior investigational agents * Concurrent low-molecular weight heparin or warfarin for deep vein thrombosis or pulmonary embolism allowed

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Otherlead

Study Sites (12)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095, United States

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

NCI - Neuro-Oncology Branch

Bethesda, Maryland, 20892-8200, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0316, United States

Related Publications (2)

Norden AD, Raizer JJ, Abrey LE, Lamborn KR, Lassman AB, Chang SM, Yung WK, Gilbert MR, Fine HA, Mehta M, Deangelis LM, Cloughesy TF, Robins HI, Aldape K, Dancey J, Prados MD, Lieberman F, Wen PY. Phase II trials of erlotinib or gefitinib in patients with recurrent meningioma. J Neurooncol. 2010 Jan;96(2):211-7. doi: 10.1007/s11060-009-9948-7. Epub 2009 Jun 28.
PMID: 19562255BACKGROUND
Lassman AB, Rossi MR, Raizer JJ, Abrey LE, Lieberman FS, Grefe CN, Lamborn K, Pao W, Shih AH, Kuhn JG, Wilson R, Nowak NJ, Cowell JK, DeAngelis LM, Wen P, Gilbert MR, Chang S, Yung WA, Prados M, Holland EC. Molecular study of malignant gliomas treated with epidermal growth factor receptor inhibitors: tissue analysis from North American Brain Tumor Consortium Trials 01-03 and 00-01. Clin Cancer Res. 2005 Nov 1;11(21):7841-50. doi: 10.1158/1078-0432.CCR-05-0421.
PMID: 16278407

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsMeningiomaGlioblastomaAstrocytomaOligodendrogliomaGlioma, SubependymalGliomaGliosarcoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain Diseases

Study Officials

Frank S. Lieberman, MD
University of Pittsburgh
STUDY CHAIR

Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

p450

nonp450

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (12)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

p450

nonp450

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (12)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations