Topotecan in Treating Children With Refractory Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of topotecan in treating children with refractory leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Topotecan

Criteria

DISEASE CHARACTERISTICS:

-Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists

PATIENT CHARACTERISTICS:

• Age: Under 21

• Performance status: ECOG 0-2

• Life expectancy: At least 8 weeks

• Adequate platelet count and hemoglobin required (transfusion allowed)

• Bilirubin no greater than 1.5 mg/dL

• AST or ALT no greater than 2 times normal

• Creatinine less than 1.5 mg/dL

• Adequate nutritional status, e.g. higher than third percentile weight for height

• Albumin at least 3 g/dL

• No severe uncontrolled infection

• No pregnant women

• Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

• At least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas)

• Recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation)

• No concurrent anticancer therapy

• No concurrent treatment studies