Raltitrexed in Treating Children With Refractory Acute Leukemia

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

Summary

Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. 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: Raltitrexed

Criteria

Inclusion Criteria:

• Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists

• No CNS leukemia

• No solid tumors

• Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)

• Life expectancy: At least 8 weeks

• Bilirubin less than 1.5 mg/dL

• SGPT less than 5 times normal

• Normal creatinine for age OR GFR at least 70 mL/min

• No significant systemic illness such as infection

• No significant third space fluid collection

• Not pregnant or nursing

• Recovered from acute toxic effects of prior immunotherapy

• At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease

• At least 10 days since prior biologic therapy

• At least 1 week since prior growth factors

• At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered

• No concurrent steroids

• Recovered from acute toxic effects of all prior radiotherapy

• At least 2 weeks since prior local palliative radiotherapy (small port)

• At least 6 months since prior substantial bone marrow radiation

• No other concurrent anticancer therapy or investigational agents

• No concurrent nonsteroidal anti-inflammatory agents