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)

December 21, 2015 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: COPP/ABV
4 courses of COPP/ABV hybrid
Other Names:
  • Cyclophosphamide
  • Adriamycin
  • Prednisone
  • Vincristine
  • Vinblastine
  • Procarbazine
  • Bleomycin
Drug: COPP/ABV
6 courses of COPP/ABV hybrid
Other Names:
  • Cyclophosphamide
  • Adriamycin
  • Prednisone
  • Vincristine
  • Vinblastine
  • Procarbazine
  • Bleomycin
Experimental: 2
Drug: COPP/ABV
4 courses of COPP/ABV hybrid
Other Names:
  • Cyclophosphamide
  • Adriamycin
  • Prednisone
  • Vincristine
  • Vinblastine
  • Procarbazine
  • Bleomycin
Drug: COPP/ABV
6 courses of COPP/ABV hybrid
Other Names:
  • Cyclophosphamide
  • Adriamycin
  • Prednisone
  • Vincristine
  • Vinblastine
  • Procarbazine
  • Bleomycin
Experimental: 3
Drug: intensive chemo with concurrent growth factor
6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor
Other Names:
  • Cytosine Arabinoside
  • Cyclophosphamide
  • Adriamycin
  • Prednisone
  • Etoposide
  • Vincristine
  • Vinblastine
  • Procarbazine
  • Bleomycin
  • G-CSF (Filgrastim)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Children's Cancer Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1996

Primary Completion (Actual)

February 1, 1999

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-016
  • CCG 5942
  • CA42764

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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