Prolonged Daily Temozolomide for Low-Grade Glioma

Completed · Phase 2

Conditions studied: Glioma, Astrocytoma, Oligodendroglioma

In brief

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.

Key facts

Study ID

NCT00165360

Run by

Dana-Farber Cancer Institute

People needed

46

Starts

2001-09-01

Expected to finish

2009-09-01

Last updated by the study team

2009-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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