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)
Status and phase
Completed
Phase 2
Conditions
Hodgkin's Disease
Pediatric
Treatments
Drug: COPP/ABV
Drug: intensive chemo with concurrent growth factor
Details and patient eligibility
About
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.
Enrollment
21 patients
Sex
All
Ages
Under 21 years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
21 participants in 3 patient groups
1
Experimental group
Treatment:
Drug: COPP/ABV
Drug: COPP/ABV
2
Experimental group
Treatment:
Drug: COPP/ABV
Drug: COPP/ABV
3
Experimental group
Treatment:
Drug: intensive chemo with concurrent growth factor
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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