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)

NCT ID: NCT00592111

Last Updated: 2015-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Hodgkin's Disease

Keywords

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Pediatric Hodgkin's Disease 96-016

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

COPP/ABV

Intervention Type DRUG

4 courses of COPP/ABV hybrid

2

Group Type EXPERIMENTAL

COPP/ABV

Intervention Type DRUG

6 courses of COPP/ABV hybrid

3

Group Type EXPERIMENTAL

intensive chemo with concurrent growth factor

Intervention Type DRUG

6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor

Interventions

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COPP/ABV

4 courses of COPP/ABV hybrid

Intervention Type DRUG

COPP/ABV

6 courses of COPP/ABV hybrid

Intervention Type DRUG

intensive chemo with concurrent growth factor

6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor

Intervention Type DRUG

Other Intervention Names

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Cyclophosphamide Vincristine Procarbazine Prednisone Adriamycin Bleomycin Vinblastine Cyclophosphamide Vincristine Procarbazine Prednisone Adriamycin Bleomycin Vinblastine Cyclophosphamide Vincristine Procarbazine Prednisone Adriamycin Bleomycin Vinblastine Cytosine Arabinoside Etoposide G-CSF (Filgrastim)

Eligibility Criteria

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Inclusion 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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Cancer Group

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanya Trippett, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CCG 5942

Identifier Type: -

Identifier Source: secondary_id

CA42764

Identifier Type: -

Identifier Source: secondary_id

96-016

Identifier Type: -

Identifier Source: org_study_id