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CompletedNCT00083070Updated Feb 20, 2014

Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia

A Phase 1 interventional study of temozolomide in Leukemia, sponsored by Children's Oncology Group. Completed at 16 sites in 2 countries. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2014-02-20.

Sponsored by Children's Oncology Group · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
1 Year to 21 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Leukemia

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Keywords

  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • relapsing chronic myelogenous leukemia
  • childhood acute promyelocytic leukemia (M3)
  • blastic phase chronic myelogenous leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 16 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Temozolomide Therapy

    Drug: temozolomide

Interventions

  • Drugtemozolomide

    Also known as: Temodar, NSC # 362856

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose and recommended phase II dose

  2. Toxicity as assessed by CTCAE 3.0

  3. Pharmacokinetics as assessed by CI, area under the curve (AUC), and half-life (T ½)

Secondary outcomes

  1. Antitumor activity

  2. Biologic activity and mechanisms of resistance

07

Study locations

16 sites
  • Stanford Cancer Center at Stanford University Medical Center
    Stanford, California 94305, United States
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202-5289, United States
  • Fairview University Medical Center - University Campus
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216-4505, United States
  • Herbert Irving Comprehensive Cancer Center at Columbia University
    New York, New York 10032, United States
  • SUNY Upstate Medical University Hospital
    Syracuse, New York 13210, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229-3039, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104-9786, United States
  • Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
    Dallas, Texas 75390, United States
  • Baylor University Medical Center - Houston
    Houston, Texas 77030-2399, United States
  • Children's Hospital and Regional Medical Center - Seattle
    Seattle, Washington 98105, United States
  • Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
  • Hopital Sainte Justine
    Montreal, Quebec H3T 1C5, Canada
08

References and documents

Publications

  • 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. PubMed 17971589 ↗
  • 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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00083070
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 17, 2004
Start date
Mar 2004
Primary completion
Sep 2004
Completion
Jun 2008
Last update
Feb 20, 2014

Study contacts

Terzah M. Horton, MD, PhD
study chair · Texas Children's Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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