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Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) 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 Topotecan (NSC #609699) Plus BCNU (NSC #409962)


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.

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 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

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:

0224

NCT ID:

NCT00002986

Start Date:

February 1997

Completion Date:

May 2004

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 CenterDurham, North Carolina  27710
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794