Irofulven in Treating Children With Recurrent or 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 irofulven in treating children with recurrent or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven recurrent or refractory solid tumors

• No leukemia

• Patients with brain tumors are not eligible until the first 2 patients at each dose level are evaluable for toxicity

PATIENT CHARACTERISTICS:

• Age: 21 and under

• Performance status: Karnofsky 50-100% Lansky play scale 50-100% (for infants)

• Life expectancy: At least 8 weeks

• Absolute neutrophil count at least 1,000/mm3

• Hemoglobin at least 9 g/dL

• Platelet count at least 75,000/mm3

• Bilirubin less than 1.5 mg/dL

• SGPT less than 5 times upper limit of normal

• Creatinine normal for age OR GFR at least 70 mL/min

• Cardiac shortening fraction at least 27% OR institutional normal OR cardiac ejection fraction greater than 50% OR institutional normal

• Neurologic deficits in patients with CNS tumors must be stable for at least 2 weeks

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after the study

• No uncontrolled infection

PRIOR CONCURRENT THERAPY:

• At least 1 week since prior growth factor therapy and recovered

• At least 6 months since prior bone marrow transplantation and no evidence of graft versus host disease

• At least 2 weeks since prior myelosuppressive chemotherapy and recovered

• At least 6 weeks since prior nitrosourea and recovered

• At least 2 weeks on stable dexamethasone for patients with CNS tumors

• No concurrent chemotherapy

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

• At least 6 months since prior substantial bone marrow radiation

• At least 6 months since total abdominal, pelvic, chest, mantle, and Y ports radiotherapy

• No other concurrent anticancer therapy or investigational agents