RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplasticoligodendrogliomas or mixed anaplastic oligoastrocytomas.

Condition	Treatment or Intervention	Phase
adult anaplastic oligodendroglioma Mixed Gliomas	Drug: temozolomide  Procedure: chemotherapy  Procedure: neoadjuvant therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
• Determine the toxicity of this regimen in these patients.
• Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response [PR] vs complete response [CR]).

Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.

Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.

Patients with CR after completion of neoadjuvant temozolomide undergo observation.

Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma
• Unifocal or multifocal disease
• Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy
• No equivocal oligodendroglial element
• No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
• No spinal cord tumors
• No evidence of spinal drop metastasis or spread to noncontiguous meninges

PATIENT CHARACTERISTICS: Age:

• 18 to 65

Performance status:

• Zubrod 0-1

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 2 times normal
• AST no greater than 3 times normal
• Alkaline phosphatase no greater than 2 times normal

Renal:

• Creatinine no greater than 1.5 times normal

Other:

• No active infection
• No other medical problems that would preclude study participation
• No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• No prior chemotherapy for this malignancy
• No prior temozolomide

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to the brain, head, or neck

Surgery:

• At least 14 days since prior surgery requiring general anesthesia

Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36652-2144,  United States
Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
      Foundation for Cancer Research and Education, Phoenix,  Arizona,  85013,  United States
Florida
      Baptist Hospital of Miami, Miami,  Florida,  33256-2110,  United States
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
      Shands Cancer Center at the University of Florida Health Science Center, Gainesville,  Florida,  32610-0385,  United States
      University of Miami Sylvester Cancer Center, Miami,  Florida,  33136,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
Nebraska
      Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha,  Nebraska,  68114-4199,  United States
New Jersey
      Monmouth Medical Center, Long Branch,  New Jersey,  07740-6395,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Rutherford Hospital, Rutherfordton,  North Carolina,  28139-0000,  United States
      Wayne Memorial Hospital, Inc., Goldsboro,  North Carolina,  27533,  United States
Ohio
      Adena Regional Medical Center, Chillicothe,  Ohio,  45601,  United States
      Akron City Hospital, Akron,  Ohio,  44304,  United States
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States
      Fairfield Medical Center, Lancaster,  Ohio,  43130,  United States
      Grady Memorial Hospital, Delaware,  Ohio,  43015,  United States
      Licking Memorial Hospital, Newark,  Ohio,  43055-2899,  United States
      Mount Carmel West Hospital, Columbus,  Ohio,  43222,  United States
      Riverside Methodist Hospital, Columbus,  Ohio,  43214,  United States
      Strecker Cancer Center at Marietta Memorial Hospital, Marietta,  Ohio,  45750-1635,  United States
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States
Pennsylvania
      Mercy Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15219,  United States
South Carolina
      Anderson Area Cancer Center, Anderson,  South Carolina,  29621-5705,  United States
Utah
      Cottonwood Hospital Medical Center, Murray,  Utah,  84107,  United States
      Dixie Regional Medical Center, Saint George,  Utah,  84770,  United States
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States
      McKay-Dee Hospital Center, Ogden,  Utah,  84403,  United States
      University of Utah Health Sciences Center, Salt Lake City,  Utah,  84132,  United States
      Utah Valley Regional Medical Center - Provo, Provo,  Utah,  84604,  United States
Washington
      University Cancer Center at University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States
      Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601,  United States
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
Canada, New Brunswick
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada

Study chairs or principal investigators

Michael A. Vogelbaum, MD, PhD,  Study Chair,  Cleveland Clinic Cancer Center   

Study ID Numbers:  CDR0000069270; RTOG-BR-0131; RTOG-DEV-1080
Record last reviewed:  February 2005
Last Updated:  February 24, 2005
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033280
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08