RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with recurrent brain tumor.

Condition	Treatment or Intervention	Phase
adult anaplastic oligodendroglioma Mixed Gliomas recurrent adult brain tumor	Drug: topotecan	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and quantitative toxicity of topotecan in this patient population on this schedule.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients will be followed every 3 months until death.

PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven recurrent anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy
• Tumors for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements
• Tumors must be clinically aggressive for patients with only 1 anaplastic feature
• Prior low grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical or radiological progression are eligible
• Bidimensionally measurable and progressive lesions by CT or MRI

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 6 weeks since chemotherapy; No more than 1 prior chemotherapy regimen; No prior camptothecin derivatives
• Endocrine therapy: At least 2 weeks on stable steroid therapy, if necessary
• Radiotherapy: At least 2 months since prior radiotherapy; No prior radiation therapy for recurrent disease
• Surgery: At least 6 weeks since prior surgery (except biopsy only); Prior surgery for recurrent disease allowed (including stereotactic biopsy or partial resection)
• Other: No concurrent experimental drugs or anticancer therapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-3
• Life expectancy: Not specified
• Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Not specified
• Renal: Creatinine normal
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; No prior malignancies except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer; No other serious illness or medical condition; No active uncontrolled infection; No history of neurologic or psychiatric disorder

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada
Canada, British Columbia
      BC Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada
Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Kingston Regional Cancer Centre, Kingston,  Ontario,  K7L 5P9,  Canada
      Ottawa Regional Cancer Centre - Civic Campus, Ottawa,  Ontario,  K1Y 4K7,  Canada
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada
Canada, Quebec
      Centre Hospitalier de l'Universite de Montreal, Montreal,  Quebec,  H2L-4M1,  Canada
      McGill University Department of Oncology, Montreal,  Quebec,  H2W 1S6,  Canada

Study chairs or principal investigators

Karl Belanger,  Study Chair,  National Cancer Institute of Canada   

Study ID Numbers:  CDR0000066362; CAN-NCIC-IND109
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003372
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08