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Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

This study has been completed.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002756
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.

PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Childhood   

ChemIDplus related topics:   Cyclophosphamide    Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Mercaptopurine    6-Mercaptopurine    L-Asparaginase    Daunorubicin hydrochloride    Daunorubicin    Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Prednisone    Vincristine sulfate    Vincristine    Etoposide phosphate    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   INDUCTION INTENSIFICATION AND ALLOGENEIC BONE MARROW TRANSPLANT IN INFANT ALL: A PEDIATRIC ONCOLOGY GROUP PILOT STUDY Induction Intensification and Allogeneic Bone Marrow Transplant in Infant ALL: A Children's Oncology Group Pilot Study

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

Primary Outcome Measures:
  • Feasibility of intensification [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Comparison of event-free survival rates in infants with and without leukemic blasts translocations [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome [ Designated as safety issue: No ]
  • Clinical prognostic features associated with outcome [ Designated as safety issue: No ]
  • Correlation of biologic characteristics of leukemia cells at diagnosis with outcome [ Designated as safety issue: No ]
  • Patterns of gene expression [ Designated as safety issue: No ]

Estimated Enrollment:   104
Study Start Date:   June 1996

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia

    • No infants less than 36 weeks' gestation
    • CNS or testicular disease permitted
  • No B-cell ALL or acute myeloid leukemia
  • Previously untreated except for the following:

    • Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids
  • Concurrent registration on protocol POG-9900 (ALL classification study) required
  • Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study

PATIENT CHARACTERISTICS:

Age:

  • Under 1 at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No uncontrolled infection
  • Adequate major organ function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent chronic steroid treatment

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002756

Show 140 study locations  Show 140 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     ZoAnn E. Dreyer, MD     Texas Children's Cancer Center    
  More Information


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

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000064693, COG-P9407, POG-9407
First Received:   November 1, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00002756
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute lymphoblastic leukemia  
acute undifferentiated leukemia  

Study placed in the following topic categories:
Asparaginase
Prednisone
Daunorubicin
Leukemia, Lymphoid
Hydrocortisone
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Cortisol succinate
Vincristine
Leucovorin
Cyclophosphamide
6-Mercaptopurine
Etoposide phosphate
Folic Acid
Leukemia
Lymphatic Diseases
Methotrexate
Hydrocortisone acetate
Lymphoproliferative Disorders
Etoposide
Lymphoma
Cytarabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Vitamins
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids

ClinicalTrials.gov processed this record on October 10, 2008




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