Prolonged Daily Temozolomide for Low-Grade Glioma

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00165360

Collaborator

Schering-Plough (Industry), Brigham and Women's Hospital (Other), University of Virginia (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma Astrocytoma Oligodendroglioma	Drug: Temozolomide	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Prolonged Daily Temozolomide for Low-Grade Glioma

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

To determine the effects temozolomide has on low-grade gliomas [3 years]

Secondary Outcome Measures

To determine whether temozolomide is effective in preventing or delaying future tumor growth [3 years]
to determine the safety of temozolomide [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.