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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.
 
ClinicalTrials.gov Identifier: NCT00003372
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE June 9, 2004
Last Update Posted Date November 9, 2010
Study Start Date  ICMJE December 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topotecan in Treating Patients With Recurrent Brain Tumors
Official Title  ICMJE A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Drug: topotecan hydrochloride
Study Arms  ICMJE Not Provided
Publications * Bélanger K, MacDonald D, Cairncross G, Gertler S, Forsyth P, Burdette-Radoux S, Bergeron J, Soulières D, Ludwin S, Wainman N, Eisenhauer E. A phase II study of topotecan in patients with anaplastic oligodendroglioma or anaplastic mixed oligoastrocytoma. Invest New Drugs. 2003 Nov;21(4):473-80.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April¬†9,¬†2007)
30
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE December 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003372
Other Study ID Numbers  ICMJE I109
CAN-NCIC-IND109
CDR0000066362 ( Other Identifier: PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE NCIC Clinical Trials Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Karl Belanger, MD CHUM - Hotel Dieu Hospital
PRS Account Canadian Cancer Trials Group
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP