Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
NCT ID: NCT00083070
Last Updated: 2014-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2004-03-31
2008-06-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia.
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Detailed Description
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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 this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.
Secondary
* Determine the antitumor activity of this drug in these patients.
* Determine the biologic activity and mechanism(s) of resistance to this drug in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Temozolomide Therapy
temozolomide
Interventions
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temozolomide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Terzah M. Horton, MD, PhD
Role: STUDY_CHAIR
Texas Children's Cancer Center
Locations
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Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Countries
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References
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Horton TM, Thompson PA, Berg SL, Adamson PC, Ingle AM, Dolan ME, Delaney SM, Hedge M, Weiss HL, Wu MF, Blaney SM; Children's Oncology Group Study. Phase I pharmacokinetic and pharmacodynamic study of temozolomide in pediatric patients with refractory or recurrent leukemia: a Children's Oncology Group Study. J Clin Oncol. 2007 Nov 1;25(31):4922-8. doi: 10.1200/JCO.2007.12.0667.
Horton TM, Dolan E, Hegde M, et al.: A phase I study of temozolomide (Temodar®) in pediatric patients with relapsed or refractory leukemia: a Children's Oncology Group study. [Abstract] Blood 106 (11): A-4455, 2005.
Other Identifiers
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CDR0000362059
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ADVL0411
Identifier Type: OTHER
Identifier Source: secondary_id
ADVL0411
Identifier Type: -
Identifier Source: org_study_id
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