Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.

• Phase: Phase 1
• 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: Dacarbazine; Irinotecan; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial malignant primary glioma of one of the following subtypes:

• Glioblastoma multiforme

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Mixed malignant glioma

• Original histology of low-grade glioma allowed if subsequent histological confirmation of malignant glioma

• Measurable recurrent or residual primary disease by MRI

• Lesions with clearly defined margins

• Evidence of tumor recurrence or progression by MRI or CT scan

• Confirmation of true progressive disease by PET or thallium scan, magnetic resonance spectroscopy, or surgical documentation after prior interstitial brachytherapy or stereotactic radiosurgery

• No more than 3 relapses after prior chemotherapy/cytotoxic therapy (including polifeprosan 20 with carmustine implant) for phase I and no more than 2 relapses for phase II

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• 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 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 2 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No uncontrolled hypertension, unstable angina, or 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 mental incapacitation

• HIV negative

• No AIDS-related disease

• No significant ongoing alcoholism or substance abuse

• No severe nonmalignant systemic disease

• No active infection

• No other severe disease that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior interferon or thalidomide and recovered

• No concurrent anticancer immunotherapy

• No concurrent sargramostim (GM-CSF)

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

Chemotherapy:

• See Disease Characteristics

• Recovered from prior chemotherapy

• At least 2 weeks since prior vincristine

• At least 3 weeks since prior procarbazine

• At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosourea)

• Prior radiosensitizers allowed

• No prior temozolomide or irinotecan

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• At least 1 week since prior tamoxifen and recovered

• No concurrent anticancer hormonal therapy

• Phase II:

• Non-increasing dose of corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent anticancer radiotherapy

Surgery:

• See Disease Characteristics

• At least 1-3 weeks since prior surgical resection and recovered

Other:

• At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) and recovered

• Concurrent enzyme-inducing anti-epileptic drugs with or without steroids allowed

• No concurrent valproic acid as a single agent

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

• No other concurrent investigational drugs

• No concurrent participation in other clinical study