Status:
COMPLETED
Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief 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 ef...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of temozolomide in pediatric patients with refractory or recurrent leukemia. * Determine the toxic effects of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00083070
Start Date
March 1 2004
End Date
June 1 2008
Last Update
February 20 2014
Active Locations (16)
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1
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
2
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
3
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
4
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905