A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)

This study has been completed.
Sponsor:
Collaborator:
Children's Cancer Group
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00592111
First received: December 26, 2007
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.


Condition Intervention Phase
Pediatric
Hodgkin's Disease
Drug: COPP/ABV
Drug: intensive chemo with concurrent growth factor
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy [ Time Frame: Conclusion of the study ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: March 1996
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: COPP/ABV
4 courses of COPP/ABV hybrid
Other Names:
  • Cyclophosphamide
  • Vincristine
  • Procarbazine
  • Prednisone
  • Adriamycin
  • Bleomycin
  • Vinblastine
Experimental: 2 Drug: COPP/ABV
6 courses of COPP/ABV hybrid
Other Names:
  • Cyclophosphamide
  • Vincristine
  • Procarbazine
  • Prednisone
  • Adriamycin
  • Bleomycin
  • Vinblastine
Experimental: 3 Drug: intensive chemo with concurrent growth factor
6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor
Other Names:
  • Cyclophosphamide
  • Vincristine
  • Procarbazine
  • Prednisone
  • Adriamycin
  • Bleomycin
  • Vinblastine
  • Cytosine Arabinoside
  • Etoposide
  • G-CSF (Filgrastim)

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Age less than 21 years at diagnosis
  • Previously untreated, pathologically confirmed diagnosis of Hodgkin's disease.
  • Informed patient/parental consent as required by individual institution and in accordance with the Dept of Health and Human Services
  • Approval of this protocol by the individual institutional Human Subjects Review Committee.
  • Indicate Hodgkin's disease clinical stage.
  • Indicate presence or absence of "B" symptoms.
  • For Stage I and II disease indicate the following:
  • presence or absence of bulk disease
  • number of involved nodal regions
  • presence or absence of hilar adenopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592111

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Children's Cancer Group
Investigators
Principal Investigator: Tanya Trippett, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Tanya Trippett, Md, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00592111     History of Changes
Other Study ID Numbers: 96-016, CCG 5942, CA42764
Study First Received: December 26, 2007
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Pediatric
Hodgkin's Disease
96-016

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Cyclophosphamide
Cytarabine
Prednisone
Procarbazine
Vinblastine
Vincristine
Mitogens
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on August 25, 2014