Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	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

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

Resource links provided by NLM:

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 Etoposide phosphate 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

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

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
Etoposide

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

ClinicalTrials.gov processed this record on November 27, 2009