Prolonged Daily Temozolomide for Low-Grade Glioma

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Oligodendroglioma

Glioma

Astrocytoma

Treatments

Drug: Temozolomide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00165360

01-111

Details and patient eligibility

About

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.

Full description

Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide.
Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment).
Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.