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Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia

This study has been completed.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083070
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: temozolomide
Phase I

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

Drug Information available for:   Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose and recommended phase II dose [ Designated as safety issue: Yes ]
  • Toxicity as assessed by CTCAE 3.0 [ Designated as safety issue: Yes ]
  • Pharmacokinetics as assessed by CI, area under the curve (AUC), and half-life (T ½) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Biologic activity and mechanisms of resistance [ Designated as safety issue: No ]

Study Start Date:   March 2004

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 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.

  Eligibility
Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083070

Locations
United States, California
Stanford Cancer Center at Stanford University Medical Center    
      Stanford, California, United States, 94305
United States, Indiana
Indiana University Cancer Center    
      Indianapolis, Indiana, United States, 46202-5289
United States, Minnesota
Fairview University Medical Center - University Campus    
      Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center    
      Jackson, Mississippi, United States, 39216-4505
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University    
      New York, New York, United States, 10032
SUNY Upstate Medical University Hospital    
      Syracuse, New York, United States, 13210
United States, Ohio
Cincinnati Children's Hospital Medical Center    
      Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104-9786
Children's Hospital of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital    
      Memphis, Tennessee, United States, 38105
United States, Texas
Baylor University Medical Center - Houston    
      Houston, Texas, United States, 77030-2399
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas    
      Dallas, Texas, United States, 75390
United States, Washington
Children's Hospital and Regional Medical Center - Seattle    
      Seattle, Washington, United States, 98105
Canada, Ontario
Hospital for Sick Children    
      Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine    
      Montreal, Quebec, Canada, H3T 1C5

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Terzah M. Horton, MD, PhD     Texas Children's Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000362059, COG-ADVL0411
First Received:   May 14, 2004
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00083070
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
recurrent childhood acute myeloid leukemia  
relapsing chronic myelogenous leukemia  
childhood acute promyelocytic leukemia (M3)  
blastic phase chronic myelogenous leukemia  

Study placed in the following topic categories:
Blast Crisis
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Chronic myelogenous leukemia
Acute myelogenous leukemia
Acute promyelocytic leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Temozolomide
Recurrence
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Promyelocytic, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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