Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed 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 PSC-833 plus etoposide and mitoxantrone in treating children who have refractory or relapsed acute leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining PSC-833 with chemotherapy may reduce resistance to the drug and allow more cancer cells to be killed.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etoposide; Etoposide phosphate; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Acute myeloid leukemia (AML) in one of the following categories:

• First relapse if initial CR less than 6 months

• Refractory to first or second induction with daunomycin, cytarabine, and thioguanine (DAT) or other anthracycline-containing regimens

• Relapse following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant

• Presentation with secondary AML or AML evolving from myelodysplastic syndrome --Acute lymphocytic leukemia in one of the following categories:

• In second or subsequent relapse or failed second or later induction attempts regardless of prior remissions

• Relapsed following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant

• No isolated CNS or extramedullary relapse

PATIENT CHARACTERISTICS:

• Age: Under 22 at diagnosis

• Performance status: Karnofsky 50-100% (ECOG 0-2)

• Lansky 40-100% (in patients under 12 years of age)

• Life expectancy: At least 8 weeks

• Bilirubin less than 1.5 mg/dL

• ALT less than twice normal

• Creatinine normal for age (within 2 standard deviations) OR glomular filtration rate at least 70 mL/min

• Albumin at least 3 g/dL

• Ejection fraction greater than 50% at rest or with 5% increase with exercise OR shortening fraction greater than 27% by echocardiogram

• No history of clinical heart failure

• No uncontrolled infection

• No anticonvulsant therapy

• No history of allergic reactions or anaphylaxis to etoposide not remediable by premedication

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Third percentile weight for height

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since chemotherapy and recovered

• Prior cumulative anthracycline dose no greater than 360 mg per square meter

• Hydroxyurea therapy allowed just prior to study for rapidly rising blast count