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Topotecan in Treating Patients With Recurrent Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003372
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : March 27, 2020
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: topotecan hydrochloride Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma
Actual Study Start Date : December 8, 1997
Actual Primary Completion Date : October 5, 2000
Actual Study Completion Date : December 21, 2009

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003372

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

Publications of Results:
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Responsible Party: NCIC Clinical Trials Group Identifier: NCT00003372    
Other Study ID Numbers: I109
CDR0000066362 ( Other Identifier: PDQ )
First Posted: June 9, 2004    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
recurrent adult brain tumor
adult anaplastic oligodendroglioma
adult mixed glioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents