Prolonged Daily Temozolomide for Low-Grade Glioma

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Schering-Plough; University of Virginia
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma)

• Measurable disease on MRI

• Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery.

• Patients with recurrent disease my have had one prior chemotherapy regimen

• Older than 18 years of age.

• Karnofsky performance status (KPS) performance score of > 70%

• Adequate hematologic, renal and liver functions,

• Life expectancy of greater than 12 weeks.

• Negative pregnancy test.

Exclusion Criteria:

• Prior treatment with temozolomide

• Patients who are not neurologically stable

• Acute infection treated with intravenous antibiotics

• Non-malignant systemic disease

• Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication.

• Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin.

• HIV positive or AIDS-related illness

• Pregnant or nursing women

• Patients with allergy to decarbazine.