Gemcitabine in Treating Children With Refractory Solid Tumors

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

Summary

Phase I trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant solid tumor Confirmation made at original diagnosis

• No bone marrow involvement

• Refractory to conventional therapy and other therapies of higher priority according to CCG Phase I/II Priority List

PATIENT CHARACTERISTICS:

• Age: 1 to 21

• Performance status: 0-2

• Life expectancy: At least 2 months

• Absolute neutrophil count at least 1,000/mm3

• Platelet count at least 100,000/mm3 (transfusion independent)

• Hemoglobin at least 10 g/dL (transfusions allowed)

• Bilirubin no greater than 1.5 times normal

• AST less than 2.5 times normal

• Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope GFR at least 70 mL/min

• No seizure disorder Not pregnant or nursing

• Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior cytokine therapy and recovered

• No prior bone marrow transplantation

• No more than 3 prior combination or single agent chemotherapy regimens

• At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered