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Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
This study has been completed.
First Received: November 12, 2002   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049569
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
 Biological: filgrastim
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: imatinib mesylate
Drug: leucovorin calcium
Drug: methotrexate
Drug: pegaspargase
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
 Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Hydrocortisone acetate Cyclophosphamide Hydrocortisone Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Etoposide Citrovorum factor Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Myocet Filgrastim Pegaspargase Imatinib Imatinib mesylate Hydrocortisone 21-sodium succinate Cytarabine Hydrocortisone cypionate Leucovorin Calcium Vincristine sulfate Cortisol succinate Cortisol 21-phosphate Folinic acid calcium salt pentahydrate L-Asparaginase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Intensive Induction Therapy For Children With Acute Lymphoblastic Leukemia (ALL) Who Experience A Bone Marrow Relapse

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

Study Start Date: January 2003
  Show Detailed Description

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow)

    • Philadelphia chromosome-positive patients eligible with or without extramedullary disease
    • No prior isolated extramedullary relapse
  • No B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique)
  • No Down syndrome

PATIENT CHARACTERISTICS:

Age

  • 1 to 21 at time of relapse

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • Shortening fraction at least 28% by echocardiogram
  • Ejection fraction at least 50% by MUGA

Other

  • No active fungal infection
  • No prior invasive filamentous fungal infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 12 months since prior stem cell transplantation
  • No other concurrent immunomodulating agents

Chemotherapy

  • Prior cumulative anthracycline exposure no greater than 350 mg/m^2
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent cytotoxic therapy
  • No concurrent immunosuppressive therapy for graft-vs-host disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049569

  Show 232 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Elizabeth A. Raetz, MD Mount Sinai School of Medicine
  More Information

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

Publications:
Raetz EA, Borowitz MJ, Devidas M, Linda SB, Hunger SP, Winick NJ, Camitta BM, Gaynon PS, Carroll WL. Reinduction platform for children with first marrow relapse in acute lymphoblastic lymphoma. J Clin Oncol. 2008 Aug 20;26(24):3971-8.
Raetz EA, Borowitz MJ, Devidas M, et al.: Outcomes of children with first marrow relapse: results from Childrens Oncology Group (COG) study AALL01P2. [Abstract] Blood 108 (11): A-1871, 2006.
Borowitz MJ, Devidas M, Hunger SP, et al.: Minimal residual disease (MRD) in childhood acute lymphoblastic leukemia (ALL) in relapse. A Children's Oncology Group (COG) study. [Abstract] Blood 104 (11): A-324, 2004.
Bhojwani D, Kang H, Moskowitz N, et al.: Biological pathways associated with relapse in childhood acute lymphoblastic leukemia: a Children's Oncology Group study. [Abstract] Blood 108 (2): 711, 2006.

Study ID Numbers: CDR0000258120, COG-AALL01P2
Study First Received: November 12, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00049569     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
non-T, non-B childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Hydrocortisone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Protein Kinase Inhibitors
Hormones
Pegaspargase
Methotrexate
Etoposide
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Vincristine
 Glucocorticoids
Doxorubicin
Imatinib
Folic Acid
Hydrocortisone acetate
Antineoplastic Agents, Phytogenic
Acute Lymphoblastic Leukemia, Childhood
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Leucovorin
Cyclophosphamide
Etoposide phosphate
Leukemia
Anti-Bacterial Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Protein Kinase Inhibitors
Hormones
Pegaspargase
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
 Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Imatinib
Neoplasms
Hydrocortisone acetate
Antineoplastic Agents, Phytogenic
Antimetabolites

ClinicalTrials.gov processed this record on May 07, 2009



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