Status:
COMPLETED
Prolonged Daily Temozolomide for Low-Grade Glioma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Schering-Plough
Brigham and Women's Hospital
Conditions:
Glioma
Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 delay...
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 temozolo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00165360
Start Date
September 1 2001
End Date
September 1 2009
Last Update
November 2 2009
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115