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Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease

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: NCT00005578
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : July 24, 2014
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 tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.


Condition or disease Intervention/treatment Phase
Cardiac Toxicity Lymphoma Biological: bleomycin sulfate Biological: filgrastim Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy Phase 3

Detailed Description:

OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I. Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more courses of chemotherapy are given. Patients whose disease remains nonresponsive or progresses go off the study. Radiotherapy may follow for others. Patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
Study Start Date : March 1997
Actual Primary Completion Date : October 2004
Actual Study Completion Date : June 2008


Arm Intervention/treatment
Experimental: Arm 1
Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin hydrochloride and etoposide on days 0 and 1, bleomycin sulfate and vincristine sulfate on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs.
Biological: bleomycin sulfate
Other Names:
  • Blenoxane
  • NSC #125066

Biological: filgrastim
Other Names:
  • GRANULOCYTE-COLONY STIMULATING FACTOR
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC #614629

Drug: cyclophosphamide
Other Names:
  • CTX
  • Cytoxan
  • NSC #26271

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

Drug: etoposide
Other Names:
  • VP-16
  • VePesid
  • NSC #141540

Drug: prednisone
Other Names:
  • Deltasone
  • Meticorten
  • Liquid Pred
  • NSC #10023

Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC #67574

Radiation: radiation therapy
Experimental: Arm 2
Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin hydrochloride and etoposide on days 0 and 1, bleomycin sulfate and vincristine sulfate on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Dexrazoxane hydrochloride on days 0, 1, and 7
Biological: bleomycin sulfate
Other Names:
  • Blenoxane
  • NSC #125066

Biological: filgrastim
Other Names:
  • GRANULOCYTE-COLONY STIMULATING FACTOR
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC #614629

Drug: cyclophosphamide
Other Names:
  • CTX
  • Cytoxan
  • NSC #26271

Drug: dexrazoxane hydrochloride
Other Names:
  • DZR
  • ADR-529
  • ZINECARD
  • ICRF-187
  • NSC #169780

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

Drug: etoposide
Other Names:
  • VP-16
  • VePesid
  • NSC #141540

Drug: prednisone
Other Names:
  • Deltasone
  • Meticorten
  • Liquid Pred
  • NSC #10023

Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC #67574

Radiation: radiation therapy



Primary Outcome Measures :
  1. Diffusing capacity of the lungs for carbon monoxide (DLCO) [ Time Frame: One year post therapy ]
    The Wilcoxon test will be used to evaluate whether DLCO values differ between the two arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease of the following stages: Stages IIB, IIIB or IV

PATIENT CHARACTERISTICS: Age: 21 or under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times upper normal limit Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Less than one week of steroids for management of airway complications Radiotherapy: No prior radiotherapy except emergency radiation to the mediastinum 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): NCT00005578


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Locations
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United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
Mount Sinai School of Medicine
New York, New York, United States, 10029
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Memorial Mission Hospital
Asheville, North Carolina, United States, 28801
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Oklahoma
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States, 73126-0307
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Baylor College of Medicine
Houston, Texas, United States, 77030
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States, 78284-7810
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
McMaster Division
Hamilton, Ontario, Canada, L8N 3Z5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Cindy Schwartz, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications of Results:
Constine LS, Marcus R, Chauvenet A, et al.: Patterns of failure after response-based, dose-dense therapy for intermediate/high risk pediatric Hodgkin's disease (POG 9425). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-37, S21, 2005.
Schwartz CL, Constine LS, London W, et al.: POG 9425: response-based, intensively timed therapy for intermediate/high stage (IS/HS) pediatric Hodgkin's disease. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1555, 2002.

Other Publications:
Schwartz CL, Tebbi CK, Constine LS: Response based therapy for pediatric Hodgkin's disease (HD): Pediatric Oncology Group (POG) protocols 9425/9426. [Abstract] Med Pediatr Oncol 37 (3): A-P219, 263, 2001.

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00005578     History of Changes
Other Study ID Numbers: 9425
COG-9425 ( Other Identifier: Children's Oncology Group )
CDR0000065359 ( Other Identifier: Clinical Trials.gov )
P9425 ( Other Identifier: Pediatric Oncology Group )
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Children's Oncology Group:
stage II childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
cardiac toxicity

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Cardiotoxicity
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Etoposide
Etoposide phosphate
Vincristine
Bleomycin
Dexrazoxane
Razoxane
Lenograstim
Sargramostim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents