Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia.

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

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed leukemia of any of the following types:

• Acute lymphoblastic leukemia

• Acute myeloid leukemia

• Chronic myelogenous leukemia in blast crisis

• Refractory or recurrent disease

• Immunophenotypic confirmation of disease at initial diagnosis or recurrence

• More than 25% blasts in the bone marrow (M3)

• Active extramedullary disease allowed except for leptomeningeal disease

• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life

• No active CNS disease

PATIENT CHARACTERISTICS:

Age

• 1 to 21

Performance status

• Karnofsky 50-100% (for patients > 10 years of age)

• Lansky 50-100% (for patients ≤ 10 years of age)

Life expectancy

• Not specified

Hematopoietic

• WBC < 30,000/mm^3 (hydroxyurea or leukapheresis allowed at the discretion of the principal investigator)

• Platelet count ≥ 20,000/mm^3 (platelet transfusions allowed)

• Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed)

Hepatic

• ALT ≤ 5 times upper limit of normal (ULN)

• Albumin ≥ 2 g/dL

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine normal for age OR

• Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min/1.73 m^2

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 7 days since prior biologic therapy, including immunotherapy

• At least 3 months since prior stem cell transplantation

• No evidence of active graft-vs-host disease

• No concurrent biologic therapy

• No concurrent immunotherapy

Chemotherapy

• Recovered from prior chemotherapy

• At least 6 weeks since prior nitrosoureas

• Prior therapy with hydroxyurea allowed for up to 24 hours before initiation of study drug

• No other concurrent chemotherapy

Endocrine therapy

• Concurrent hydrocortisone or other corticosteroids allowed as premedications prior to blood product transfusions in patients with prior severe allergic reactions

Radiotherapy

• Recovered from prior radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent anticancer agents

• No other concurrent investigational drugs