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Trial record 84 of 115 for:    cancer | butyrate

Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002744
Recruitment Status : Completed
First Posted : September 1, 2004
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia

PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: therapeutic hydrocortisone Drug: thioguanine Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1970 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia
Study Start Date : May 1996
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007


Arm Intervention/treatment
Experimental: Arm I
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977

Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.

Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U

Drug: daunorubicin hydrochloride
Other Name: NSC-82151

Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521

Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127

Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol

Drug: methotrexate
Other Name: NSC-740

Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®

Drug: prednisone
Other Name: NSC-10023

Drug: therapeutic hydrocortisone
Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752

Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574

Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Experimental: Arm 2
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977

Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.

Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U

Drug: daunorubicin hydrochloride
Other Name: NSC-82151

Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521

Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127

Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol

Drug: methotrexate
Other Name: NSC-740

Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®

Drug: prednisone
Other Name: NSC-10023

Drug: therapeutic hydrocortisone
Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752

Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574

Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Experimental: Arm 3
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977

Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.

Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U

Drug: daunorubicin hydrochloride
Other Name: NSC-82151

Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521

Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127

Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol

Drug: methotrexate
Other Name: NSC-740

Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®

Drug: prednisone
Other Name: NSC-10023

Drug: therapeutic hydrocortisone
Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752

Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574

Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Experimental: Arm 4
Therapy defined in description.
Drug: asparaginase
Other Names:
  • L-Asparaginase - Erwinia
  • NSC-106977

Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • NSC-26271.

Drug: cytarabine
Other Names:
  • Cytosine Arabinoside
  • Ara-C
  • Cytosar-U

Drug: daunorubicin hydrochloride
Other Name: NSC-82151

Drug: dexamethasone
Other Names:
  • Decadron
  • NSC-34521

Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC-123127

Drug: mercaptopurine
Other Names:
  • 6-MP
  • Purinethol

Drug: methotrexate
Other Name: NSC-740

Drug: pegaspargase
Other Names:
  • PEG Asparaginase
  • Oncaspar®

Drug: prednisone
Other Name: NSC-10023

Drug: therapeutic hydrocortisone
Drug: thioguanine
Other Names:
  • 6-TG
  • NSC-752

Drug: vincristine sulfate
Other Names:
  • Oncovin
  • NSC-67574

Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy



Primary Outcome Measures :
  1. Event Free Survival
    Primary outcome index used in examining the randomized treatment groups will be event-free survival (EFS) from the time of randomization (i.e., end of Induction), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.


Secondary Outcome Measures :
  1. Comparisons of CNS relapse incidence rates
    Comparisons of CNS relapse incidence rates for the IT MTX versus ITT groups is also planned as an important endpoint.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Newly diagnosed acute lymphoblastic leukemia (ALL) obtained by bone marrow aspirate or bone marrow biopsy No greater than 25% L3 blasts Initial white blood cell count less than 50,000/mm3 (performed at CCG institution) Massive lymphadenopathy, massive splenomegaly, and/or large mediastinal mass allowed CNS or testicular leukemia allowed Allogeneic bone marrow transplant should be considered (if donor available) for patients with Philadelphia chromosome (t[9;22][q34;q11]) or translocation (4;11)(q21;q23)

PATIENT CHARACTERISTICS: Age: 1 through 9 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: No prior treatment for ALL Biologic therapy: Not specified Chemotherapy: Intrathecal cytarabine (IT ARA-C) may begin prior to registration provided systemic chemotherapy initiated within 72 hours after IT ARA-C Endocrine therapy: See Radiotherapy At least 1 month since prior systemic steroids Steroids given for less than 48 hours allowed Inhaled corticosteroids allowed at any time Radiotherapy: Radiotherapy or dexamethasone for mediastinal mass causing superior mediastinal syndrome allowed prior to registration, if indicated Surgery: Not specified


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002744


  Hide Study Locations
Locations
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United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital of Orange County
Orange, California, United States, 92668
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
United States, Colorado
Children's Hospital of Denver
Denver, Colorado, United States, 80218
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States, 64108
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, New York
Kaplan Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Children's Hospital of Columbus
Columbus, Ohio, United States, 43205-2696
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
United States, Washington
Children's Hospital and Medical Center - Seattle
Seattle, Washington, United States, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
IWK Grace Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Linda C. Stork, MD Doernbecher Children's Hospital at Oregon Health and Science University

Publications of Results:
Malempati S, Gaynon PS, Sather H, et al.: Outcome after relapse among children with standard risk (SR) ALL treated on CCG-1952. [Abstract] Blood 104 (11): A-520, 2004.
Stork LC, Sather H, Hutchinson RJ, et al.: Comparison of mercaptopurine (MP) with thioguanine (TG) and IT methotrexate (ITM) with IT "triples" (ITT) in children with SR-ALL: results of CCG-1952. [Abstract] Blood 100 (11 Pt 1): A-585, 156a, 2002.
Stork LC, Sather H, Yanofsky R, et al.: Hyperdiploidy with trisomy 10 and TEL-AML1 expression among children with standard risk acute lymphoblastic leukemia (SR-ALL): a CCG-1952 report. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1476, 2001.
Gaynon PS, Stork L, Sather H, et al.: Leukemic progenitor cell content of pre- and post-induction chemotherapy bone marrow specimens from children with newly diagnosed or relapsed acute lymphoblastic leukemia (ALL). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-2187, 567a, 1999.
Stork LC, Erdmann G, Adamson P, et al.: Oral 6-thioguanine causes relatively mild and reversible hepatic veno-occlusive disease(VOD). J Pediatr Hematol Oncol 20: 400a, 1998.

Other Publications:
Matloub Y, Asselin BL, Stork LC, et al.: Outcome of children with T-Cell acute lymphoblastic leukemia (T-ALL) and standard risk (SR) features: results of CCG-1952, CCG-1991 and POG 9404. [Abstract] Blood 104 (11): A-680, 195a, 2004.

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00002744     History of Changes
Other Study ID Numbers: 1952
CCG-1952
CDR0000064665 ( Other Identifier: Clinical Trials.gov )
First Posted: September 1, 2004    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: July 2014
Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisone
Hydrocortisone
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cyclophosphamide
Doxorubicin
Methotrexate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Pegaspargase
Thioguanine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs