Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.

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

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma)

• Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI

• Tumor progression after prior surgery, radiotherapy, or chemotherapy

• Measurable or evaluable disease

• Failed prior standard curative or palliative therapy (phase I only)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 2,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)

• Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

• Bilirubin normal

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No myocardial infarction with the past year

• No heart failure (including cardiac insufficiency controlled by digitalis and diuretics)

• No irreversible arrhythmias requiring permanent medication

• No uncontrolled hypertension

Gastrointestinal

• No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following:

• Active peptic ulcer

• Inflammatory bowel disease

• Known intolerance to lactose

• Malabsorption syndromes

• Intestinal sub-occlusion

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No active infection

• No mentally incapacitated patients

• No other concurrent severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics

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

• No more than 1 prior chemotherapy regimen

• No other concurrent chemotherapy

Endocrine therapy

• Concurrent corticosteroids allowed if dose stable for the past 2 weeks

• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• At least 3 weeks since prior surgical resection

• No prior gastrointestinal surgery that would affect drug absorption

Other

• More than 4 weeks since prior participation in any other investigational drug study

• More than 72 hours since prior systemic antibiotics

• No concurrent H2 antagonists, antacids, or proton pump inhibitors

• If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration

• No other concurrent anticancer therapy

• No other concurrent investigational drugs

• No other concurrent immunosuppressive agents