Prolonged Daily Temozolomide for Low-Grade Glioma

Phase 2

Completed

• Conditions: Glioma; Astrocytoma; Oligodendroglioma

• Registration Number: NCT00165360
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2006-12
• Study Completion: 2009-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-30
• Last Update Posted: 2009-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the effects temozolomide has on low-grade gliomas	3 years

Secondary Outcome Measures

Name	Time	Method
To determine whether temozolomide is effective in preventing or delaying future tumor growth	3 years
to determine the safety of temozolomide	3 years

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States