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Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)


OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan administered in
combination with a fixed dose of carmustine in patients with recurrent primary malignant
glioma. II. Determine the toxic effects of irinotecan and carmustine in these patients.

OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV over
90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6. Treatment
continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences
dose limiting toxicities.

PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.

Inclusion 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 60-100%
Hematopoietic: Hematocrit greater than 29% Absolute neutrophil count greater than
1,500/mm3 Platelet count greater than 125,000/mm3 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 Pulmonary: DLCO at least 60% Other: Not pregnant Fertile
patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since prior chemotherapy No prior irinotecan or carmustine treatment failure No more than
1 prior chemotherapy regimen Endocrine therapy: Patients taking corticosteroids must be on
a stable dose for at least 1 week prior to study and the dose should not escalate over
entry dose level Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: At least
3 weeks since prior surgical resection Other: No concurrent medication that may interfere
with study results

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

0564

NCT ID:

NCT00002988

Start Date:

April 1997

Completion Date:

November 2000

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710