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Combination Chemotherapy in Treating Children or Adolescents With Newly Diagnosed Stage III or Stage IV Lymphoblastic Lymphoma

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: NCT00004228
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.

PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.


Condition Intervention Phase
Lymphoma
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Procedure: radiation therapy
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Cytarabine    Cytarabine hydrochloride    Mercaptopurine    6-Mercaptopurine    L-Asparaginase    Daunorubicin hydrochloride    Daunorubicin    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Prednisone    Vincristine sulfate    Vincristine    Calcium gluconate    Thioguanine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma

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

Primary Outcome Measures:
  • Event-free survival as assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival as assessed by time to death [ Designated as safety issue: No ]

Estimated Enrollment:   400
Study Start Date:   June 2000
Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*

    • Less than 25% tumor cells in the bone marrow
    • Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
    • Stage III or IV disease
  • NOTE: *Localized lymphblastic lymphoma is closed to accrual as of 10/2005

PATIENT CHARACTERISTICS:

Age:

  • 1 to 30

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Adequate cardiac function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy

Radiotherapy:

  • Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy

Surgery:

  • Not specified

Other:

  • No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004228

Show 176 study locations  Show 176 Study Locations

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

Investigators
Study Chair:     Minnie Abromowitch, MD     Children's Hospital    
  More Information


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

Publications of Results:
Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL. Characterization of childhood precursor T-lymphoblastic lymphoma by immunophenotyping and fluorescent in situ hybridization: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Jul 10; [Epub ahead of print]
 
Coustan-Smith E, Abromowitz M, Sandlund JT, et al.: A novel approach for minimal residual disease detection in childhood T-cell lymphoblastic lymphoma (T-LL): a Children's Oncology Group report. [Abstract] Blood 110 (11): A-3564, 2007.
 

Study ID Numbers:   CDR0000067470, COG-A5971, CCG-59701, CCG-59701C, CCG-A5971, POG-A5971
First Received:   January 28, 2000
Last Updated:   October 28, 2008
ClinicalTrials.gov Identifier:   NCT00004228
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III childhood lymphoblastic lymphoma  
stage IV childhood lymphoblastic lymphoma  

Study placed in the following topic categories:
Dexamethasone
Asparaginase
Prednisone
Daunorubicin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Thioguanine
Vincristine
Leucovorin
6-Mercaptopurine
Lymphoblastic lymphoma
Cyclophosphamide
Doxorubicin
Folic Acid
Leukemia
Lymphatic Diseases
Methotrexate
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Dexamethasone acetate

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

ClinicalTrials.gov processed this record on November 30, 2008




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