Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent or progressive malignant glioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed intracranial primary malignant glioma

• Glioblastoma multiforme

• Anaplastic astrocytoma*

• Anaplastic oligodendroglioma*

• Anaplastic mixed oligodendroglioma*

• Malignant astrocytoma (not otherwise specified)* NOTE: *Closed to accrual effective 5/28/2002

• Progressive or recurrent disease confirmed by MRI or CT scan within the past 14 days

• Stable steroid dose for at least 5-7 days

• Confirmation of true progressive disease by PET scan, thallium scan, MR spectroscopy, or surgery if prior therapy included interstitial brachytherapy or stereotactic radiosurgery

• Failed prior radiotherapy

• Phase I (phase I completed effective 10/2/2001): No more than 2 prior chemotherapy or cytotoxic regimens, including 1 prior adjuvant therapy and 1 prior regimen for progressive or recurrent disease, or 2 prior regimens for progressive disease

• Phase II (phase II open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003]): No more than 2 prior chemotherapy or cytotoxic regimens for relapsed disease following initial therapy (radiotherapy with or without chemotherapy)

• Prior surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse

• Patients who received prior therapy for a low-grade glioma with a surgical diagnosis of a high-grade glioma are considered to be in first relapse

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 2,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 2.5 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• No uncontrolled high blood pressure

• No unstable angina

• No symptomatic congestive heart failure

• No myocardial infarction within the past 6 months

• No serious uncontrolled cardiac arrhythmia

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No severe nonmalignant systemic diseases or active infections

• No other severe concurrent disease that would preclude study therapy

• No allergy to azoles (e.g., ketoconazole, itraconazole, or voriconazole)

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior interferon

• No concurrent anticancer immunotherapy

• No concurrent routine prophylactic filgrastim (G-CSF) during first course of study

• No concurrent sargramostim (GM-CSF)

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, suramin, or mitomycin)

• At least 3 weeks since prior procarbazine

• At least 2 weeks since prior vincristine

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• See Disease Characteristics

• At least 1 week since prior tamoxifen

• Concurrent corticosteroids allowed

• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent anticancer radiotherapy

Surgery:

• See Disease Characteristics

• At least 3 weeks since prior resection and recovered

• Prior recent resection of recurrent or progressive tumor allowed

Other:

• Recovered from all prior therapy (excluding neurotoxicity or alopecia)

• Prior radiosensitizers allowed

• Concurrent H2 blockers and antacids allowed provided taken at least 2 hours before and after tipifarnib

• No concurrent proton pump inhibitors (e.g., omeprazole or lansoprazole)

• No other concurrent medication that would preclude study therapy (e.g., immunosuppressive agents)

• No other concurrent anticancer therapy

• No other concurrent investigational drugs

• No concurrent participation in any other clinical study

• No other concurrent medications except analgesics, chronic treatments for concurrent medical conditions, or agents for life-threatening medical problems