Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors

• Status: Completed
• Trial end date: 2010-01-02
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of CNS tumors.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or progressive CNS tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

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