Back to resultsA Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)
Primary Purpose
Pediatric, Hodgkin's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COPP/ABV
COPP/ABV
intensive chemo with concurrent growth factor
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric focused on measuring Pediatric, Hodgkin's Disease, 96-016
Eligibility 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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00592111
First Posted
December 26, 2007
Last Updated
December 21, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Children's Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT00592111
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 1996 (undefined)
Primary Completion Date
February 1999 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Children's Cancer Group
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric, Hodgkin's Disease
Keywords
Pediatric, Hodgkin's Disease, 96-016
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
COPP/ABV
Other Intervention Name(s)
Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine
Intervention Description
4 courses of COPP/ABV hybrid
Intervention Type
Drug
Intervention Name(s)
COPP/ABV
Other Intervention Name(s)
Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine
Intervention Description
6 courses of COPP/ABV hybrid
Intervention Type
Drug
Intervention Name(s)
intensive chemo with concurrent growth factor
Other Intervention Name(s)
Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine, Cytosine Arabinoside, Etoposide, G-CSF (Filgrastim)
Intervention Description
6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Trippett, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Related Info
Learn more about this trial
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)
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