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

November 1, 1999
January 27, 2003
February 20, 2013
February 1997
May 2004   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002986 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Chemotherapy in Treating Patients With Recurrent Malignant Glioma
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: carmustine
  • Drug: topotecan hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
May 2004
May 2004   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000065521 ( Other Identifier: NCI )
Not Provided
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Study Chair: Henry S. Friedman, MD Duke Cancer Institute
Duke University
February 2013

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