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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083070 |
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 |
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Leukemia |
Drug: temozolomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Trial Of Temozolomide In Pediatric Patients With Refractory/Recurrent Leukemias |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed leukemia of any of the following types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 3 months since prior stem cell transplantation
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Terzah M. Horton, MD, PhD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000362059, COG-ADVL0411 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00083070 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia relapsing chronic myelogenous leukemia childhood acute promyelocytic leukemia (M3) blastic phase chronic myelogenous leukemia |
Acute Lymphoblastic Leukemia, Childhood Blast Crisis Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myeloid, Acute Temozolomide Recurrence Acute Myeloid Leukemia, Childhood |
Leukemia Acute Myelocytic Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Promyelocytic, Acute Antineoplastic Agents, Alkylating Chronic Myelogenous Leukemia Alkylating Agents Acute Promyelocytic Leukemia Acute Lymphoblastic Leukemia |
Leukemia Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Temozolomide Pharmacologic Actions |