Temozolomide in Treating Patients With Progressive Low-Grade Glioma

• Status: Completed
• Trial end date: 2005-07-01
• 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.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.

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

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including:

• Astrocytoma

• Oligodendroglioma

• Mixed glioma

• Optic pathway glioma*

• Pontine glioma* NOTE: *Biopsy not required

• Patients with optic pathway glioma must also meet the following criteria:

• Progressive loss of vision as defined by doubling of octaves

• Visual acuity loss not explained by other causes

• Increase in proptosis of greater than 3 mm

• Increase in diameter of optic nerve of at least 2 mm on neuroimaging

• Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• 4 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• More than 12 weeks

Hematopoietic:

• 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 less than 1.5 times upper limit of normal (ULN)

• SGOT and SGPT less than 2.5 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal:

• Creatinine less than 1.5 times ULN

• BUN less than 1.5 times ULN

Other:

• Must be neurologically stable

• No systemic disease

• No acute infection requiring IV antibiotics

• No frequent vomiting

• No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction)

• No other prior or concurrent malignancies except:

• Surgically cured carcinoma in situ of the cervix

• Basal or squamous cell skin cancer

• HIV negative

• No AIDS-related illness

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic therapy (growth factors or epoetin alfa)

Chemotherapy:

• At least 6 weeks since prior chemotherapy unless evidence of disease progression

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 6 weeks since prior radiotherapy unless evidence of disease progression

• No concurrent radiotherapy

Surgery:

• At least 3 weeks since prior surgery unless evidence of disease progression

• Recovered from all prior surgery

Other:

• No other concurrent investigational drugs