Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia

NCT00083070 | Completed Phase 1 DMC

• 3 other identifiers: ADVL0411CDR0000362059COG-ADVL0411
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 16

Brief 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.

Conditions

Leukemia

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

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose and recommended phase II dose

• Toxicity as assessed by CTCAE 3.0

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

Secondary Outcomes (2)

• Antitumor activity

• Biologic activity and mechanisms of resistance

Study Arms (1)

Temozolomide Therapy

EXPERIMENTAL

Drug: temozolomide

Interventions

temozolomide DRUG

Also known as: Temodar, NSC # 362856

Temozolomide Therapy

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Fairview University Medical Center - University Campus

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-9786, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 17971589 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Blast Crisis

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Terzah M. Horton, MD, PhD

  Texas Children's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 17, 2004
• Study Start: March 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: June 1, 2008
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

US (14); CA (2)