Prolonged Daily Temozolomide for Low-Grade Glioma

October 30, 2009 updated by: Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Temozolomide

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the effects temozolomide has on low-grade gliomas Time Frame: 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine whether temozolomide is effective in preventing or delaying future tumor growth Time Frame: 3 years	3 years
to determine the safety of temozolomide Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

University of Virginia

Schering-Plough

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria