Prolonged Daily Temozolomide for Low-Grade Glioma

NCT ID: NCT00165360

Last Updated: 2009-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2009-09-30

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.

Conditions

Glioma; Astrocytoma; Oligodendroglioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Temozolomide

Given once daily for 49 days followed by 28 days with no drug for a maximum of a year and a half

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Dana-Farber Cancer Institute

Principal Investigators

Patrick Wen, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

01-111

Identifier Type: -

Identifier Source: org_study_id