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Chemotherapy in Treating Patients With Recurrent Malignant Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00002986
First received: November 1, 1999
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
 Drug: carmustine
Drug: topotecan hydrochloride
 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Duke University:

Estimated Enrollment: 36
Study Start Date: February 1997
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine.
  • Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma.

OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.

Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional

3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.

Patients are evaluated after every 6 week cycle.

PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven recurrent primary malignant glioma

    • Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance Status:

  • Karnofsky at least 60%

Hematopoietic:

  • Hematocrit greater than 29%
  • ANC greater than 1,500/mm^3
  • Platelet count greater than 125,000/mm^3

Hepatic:

  • SGOT less than 1.5 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN

Renal:

  • Creatinine less than 1.5 mg/dL
  • BUN less than 25 mg/dL

Other:

  • Not pregnant
  • Effective contraceptive method must be used for the duration of the study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy within 6 weeks of study
  • No prior topotecan or carmustine treatment failure
  • No more than 1 prior chemotherapy regimen

Endocrine therapy:

  • Patients taking corticosteroids must be on stable dose for at least 2 weeks prior to study and the dose should not escalate over entry level

Radiotherapy:

  • No prior radiotherapy within 6 weeks of study

Surgery:

  • No prior surgical resection within 3 weeks of study

Other:

  • No concurrent medication that may interfere with study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002986

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
  More Information

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00002986     History of Changes
Other Study ID Numbers: 0224, DUMC-000224-01-1R4, DUMC-000224-00-2R3, DUMC-0348-99-2R2, DUMC-223-97-2, DUMC-229-98-2R1, SB-DUMC-229-98-2R1, NCI-G97-1242, CDR0000065521
Study First Received: November 1, 1999
Last Updated: February 15, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
recurrent adult brain tumor

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Carmustine
Topotecan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013