Phase III Trial of Anaplastic Glioma Without 1p/19q LOH

• Status: Active, not recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Cooperative Trials Group for Neuro-Oncology; Medical Research Council; Merck Sharp & Dohme Corp.; NCIC Clinical Trials Group; Radiation Therapy Oncology Group
• Treatments: Dacarbazine; Temozolomide

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, isocitrate dehydrogenase mutation analysis, 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 other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

• 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