Radiation Therapy with or without Temozolomide in Treating Patients with Anaplastic Glioma

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Asher Alban Chanan Khan, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Paul Brown, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions