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Sponsored by: |
National Cancer Institute of Canada |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003372 |
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 | Intervention | Phase |
Brain and Central Nervous System Tumors |
Drug: topotecan hydrochloride |
Phase II |
MedlinePlus related topics: | Brain Cancer Cancer |
ChemIDplus related topics: | Topotecan hydrochloride Topotecan |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma |
Estimated Enrollment: | 30 |
Study Start Date: | December 1997 |
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.
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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
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
Canada, Alberta | |||||
Cross Cancer Institute | |||||
Edmonton, Alberta, Canada, T6G 1Z2 | |||||
Tom Baker Cancer Center - Calgary | |||||
Calgary, Alberta, Canada, T2N 4N2 | |||||
Canada, British Columbia | |||||
BC Cancer Agency | |||||
Vancouver, British Columbia, Canada, V5Z 4E6 | |||||
Canada, Manitoba | |||||
CancerCare Manitoba | |||||
Winnipeg, Manitoba, Canada, R3E 0V9 | |||||
Canada, Ontario | |||||
Cancer Care Ontario-London Regional Cancer Centre | |||||
London, Ontario, Canada, N6A 4L6 | |||||
Kingston Regional Cancer Centre | |||||
Kingston, Ontario, Canada, K7L 5P9 | |||||
Ottawa Regional Cancer Centre - Civic Campus | |||||
Ottawa, Ontario, Canada, K1Y 4K7 | |||||
Princess Margaret Hospital | |||||
Toronto, Ontario, Canada, M5G 2M9 | |||||
Toronto Sunnybrook Regional Cancer Centre | |||||
Toronto, Ontario, Canada, M4N 3M5 | |||||
Canada, Quebec | |||||
Centre Hospitalier de l'Universite de Montreal | |||||
Montreal, Quebec, Canada, H2L-4M1 | |||||
McGill University Department of Oncology | |||||
Montreal, Quebec, Canada, H2W 1S6 |
National Cancer Institute of Canada |
Study Chair: | Karl Belanger, MD | CHUM - Hotel Dieu Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066362, CAN-NCIC-IND109 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003372 |
Health Authority: | United States: Federal Government |
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