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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00004010
Registration number
NCT00004010
Ethics application status
Date submitted
1/11/1999
Date registered
15/04/2004
Date last updated
26/02/2014
Titles & IDs
Public title
Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II, Stage III, or Stage IV Hodgkin's Disease
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Scientific title
Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy
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Secondary ID [1]
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COG-59704
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Secondary ID [2]
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59704
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - bleomycin sulfate
Other interventions - filgrastim
Treatment: Drugs - ABVD regimen
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - dacarbazine
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - prednisone
Treatment: Drugs - procarbazine hydrochloride
Treatment: Drugs - vinblastine sulfate
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy
Experimental: BEACOPP therapy - Patients receive 4 cycles of BEACOPP therapy. Drugs utilized in this regimen include Bleomycin (B), Etoposide (E), Doxorubicin (A), Cyclophosphamide (C), Vincristine (O), Prednisone (P) and Procarbazine (P). Each cycle lasts 21 days and is characterized by intravenous pulses of Etoposide (Days 0-2), Doxorubicin (Day 0), Cyclophosphamide (Day 0), Bleomycin (Day 7), Vincristine (Day 7). Seven days of oral procarbazine (Days 0-6) and 14 days of oral prednisone (Days 0-13) are given during each cycle.
Growth factor support with Filgrastim (G-CSF) is given by subcutaneous injection daily beginning Day 8. Response will then be determined and stratification for further treatment.
Other interventions: bleomycin sulfate
Other interventions: filgrastim
Treatment: Drugs: ABVD regimen
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: dacarbazine
Treatment: Drugs: doxorubicin hydrochloride
Treatment: Drugs: etoposide
Treatment: Drugs: prednisone
Treatment: Drugs: procarbazine hydrochloride
Treatment: Drugs: vinblastine sulfate
Treatment: Drugs: vincristine sulfate
Treatment: Other: radiation therapy
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Intervention code [1]
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Other interventions
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Treatment: Drugs
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Estimate the rate of BEACOPP )((Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone) specific toxicity in pediatric patients
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Obtain preliminary estimates of response to BEACOPP ((Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically proven, previously untreated Hodgkin's disease
Stage IV OR Stage II or stage III with B symptoms (at least 1 of the following: unexplained
weight loss greater than 10%, unexplained recurrent fever greater than 39 degrees C, or
drenching night sweats) AND bulk disease (defined as a mediastinal mass greater than 1/3 of
mediastinal thoracic diameter and/or nodal aggregate greater than 10.0 cm) The following
cellular types are eligible: Mixed cellularity, not otherwise specified (NOS) Lymphocytic
depletion, NOS Lymphocytic depletion, diffuse fibrosis Lymphocytic depletion, reticular
Lymphocytic predominance, NOS Lymphocytic predominance, diffuse Lymphocytic predominance,
nodular Hodgkin's paragranuloma Hodgkin's granuloma Hodgkin's sarcoma Nodular sclerosis,
NOS Nodular sclerosis, cellular phase Nodular sclerosis, lymphocytic predominance Nodular
sclerosis, mixed cellularity Nodular sclerosis, lymphocytic depletion Hodgkin's disease,
NOS Must begin protocol therapy within 42 days of biopsy and 7 days of completion of
staging
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior treatment for Hodgkin's disease
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Minimum age
No limit
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Maximum age
21
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/1999
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2008
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Sample size
Target
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Accrual to date
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Final
99
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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California
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Colorado
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District of Columbia
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Illinois
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Indiana
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Tennessee
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Wisconsin
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Canada
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British Columbia
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Canada
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Nova Scotia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy
after chemotherapy may be an effective treatment for Hodgkin's disease.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation
therapy in treating children who have previously untreated stage II, stage III, or stage IV
Hodgkin's disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00004010
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kara Kelly, MD
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Address
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Herbert Irving Comprehensive Cancer Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00004010
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