Chemotherapy in Treating Patients With Recurrent Malignant Glioma

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: NCT00002986
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):
Duke University

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine Drug: topotecan hydrochloride Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
Study Start Date : February 1997
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven recurrent primary malignant glioma

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



  • 18 and over

Performance Status:

  • Karnofsky at least 60%


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


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


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


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


Biologic therapy:

  • Not specified


  • 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


  • No prior radiotherapy within 6 weeks of study


  • No prior surgical resection within 3 weeks of study


  • No concurrent medication that may interfere with study results

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): NCT00002986

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
Study Chair: Henry S. Friedman, MD Duke Cancer Institute

Responsible Party: Duke University Identifier: NCT00002986     History of Changes
Other Study ID Numbers: 0224
CDR0000065521 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Duke University:
recurrent adult brain tumor

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