Radiation Therapy With or Without Temozolomide in Treating Patients With Anaplastic Glioma
Status: Recruiting
Phase:
Diagnosis: Brain/Neuro Cancer: Other Non-Glioblastoma
NCT ID: NCT00626990
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-460
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Conducting Institutions:
Brigham and Women's Hospital, Massachusetts General Hospital, Dana-Farber Cancer Institute
Overall PI:
Patrick Wen, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Helen Shih, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Lisa Doherty,
ldoherty1@partners.org
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Anaplastic astrocytoma
- Newly diagnosed disease
- Prior surgery for a low grade tumor is allowed, provided histological confirmation of
an anaplastic tumor is present at the time of progression
- Absence of combined 1p/19q loss
- Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA
methyltransferase promoter methylation status assessment, and central pathology
review
- Patients must be on a stable or decreasing dose of steroids for at least two weeks
prior to randomization
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1.5 x 10^9 cells/L
- Platelet count ≥ 100 x 10^9 cells/L
- Bilirubin < 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 x ULN
- AST and ALT < 2.5 x ULN
- Serum creatinine < 1.5 x ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known HIV infection or chronic hepatitis B or hepatitis C infection
- No other serious medical condition that would interfere with follow-up
- No medical condition that could interfere with oral medication intake (e.g., frequent
vomiting or partial bowel obstruction)
- No prior or concurrent malignancies at other sites except for surgically cured
carcinoma in situ of the cervix or nonmelanoma skin cancer
- No psychological, familial, sociological, or geographical condition that would
potentially hamper compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
- No prior radiotherapy to the brain
- No concurrent growth factors unless vital for the patient
- No other concurrent investigational treatment
- No other concurrent anticancer agents