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

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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

Tracking Information
First Submitted Date  ICMJE May 2, 2000
First Posted Date  ICMJE May 26, 2004
Last Update Posted Date July 24, 2014
Study Start Date  ICMJE March 1997
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease
Official Title  ICMJE Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
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.

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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Toxicity
  • Lymphoma
Intervention  ICMJE
  • 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
Study Arms
  • 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.
    Interventions:
    • Biological: bleomycin sulfate
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisone
    • Drug: vincristine sulfate
    • 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
    Interventions:
    • Biological: bleomycin sulfate
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: dexrazoxane hydrochloride
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisone
    • Drug: vincristine sulfate
    • Radiation: radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2014)
219
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date June 2008
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00005578
Other Study ID Numbers  ICMJE 9425
COG-9425 ( Other Identifier: Children's Oncology Group )
CDR0000065359 ( Other Identifier: Clinical Trials.gov )
P9425 ( Other Identifier: Pediatric Oncology Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor  ICMJE Children's Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Cindy Schwartz, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Children's Oncology Group
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP