Completed

A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias

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What is being tested

temozolomide

Drug
Who is being recruted

Hematologic Diseases
+1

+ Leukemia
+ Neoplasms
From 1 to 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias 
NCT00083070
Principal SponsorChildren's Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
16 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 1 to 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hematologic Diseases
Leukemia
Neoplasms
Neoplasms by Histologic Type
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 16 locations
Suspended
Stanford Cancer Center at Stanford University Medical CenterStanford, United StatesSee the location
Suspended
Indiana University Cancer CenterIndianapolis, United States
Suspended
Fairview University Medical Center - University CampusMinneapolis, United States
Suspended
Mayo Clinic Cancer CenterRochester, United States

Completed16 Study Centers
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