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Topotecan in Treating Patients With Recurrent Brain Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003372
  Purpose

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   December 1997

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003372

Locations
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

Sponsors and Collaborators
National Cancer Institute of Canada

Investigators
Study Chair:     Karl Belanger, MD     CHUM - Hotel Dieu Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

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

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  
adult anaplastic oligodendroglioma  
mixed gliomas  

Study placed in the following topic categories:
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Topotecan
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Neoplasms, Neuroepithelial
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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