Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
NCT ID: NCT00398554
Last Updated: 2020-03-26
Study Results
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Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2005-06-30
2013-03-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects and how well combination chemotherapy works in treating young male patients with Hodgkin's lymphoma.
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Detailed Description
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* Determine the safety and efficacy of combination chemotherapy comprising vincristine, etoposide, cyclophosphamide, vinblastine, prednisone, and doxorubicin hydrochloride (VECOPA) in pediatric male patients with previously untreated stage II-IV classic Hodgkin's lymphoma.
* Compare the effects of VECOPA vs cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone (COPP) in these patients.
OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (IA/B\[E\], IIA\[E\], IIB, or IIIA vs IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B).
* Stratum 1 (stages IA/B\[E\], IIA\[E\], IIB, or IIIA): Patients receive oral prednisone on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin hydrochloride IV over 4 hours on days 1 and 15, and etoposide IV over 2 hours on days 2-6 (OEPA). Treatment repeats every 4 weeks for 2 courses. Beginning at week 9, patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34, etoposide IV over 2 hours on days 1-3, doxorubicin hydrochloride IV over 2 hours on day 21, vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21, and vincristine IV on days 8 and 29. Patients then undergo radiotherapy.
* Stratum 2 (stages IIB\[E\], IIIA/B\[E\], IIIB, or IVA/B): Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA (6-week courses). Patients then undergo radiotherapy.
After completion of study treatment, patients are followed periodically for at least 6 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VECOPA
dose and time intensified consoloditation chemotherapy cycle
cyclophosphamide
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
doxorubicin hydrochloride
25mg/m²/day, 2 hours i.v.infusion on day 21
etoposide
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
prednisone
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
vinblastine sulfate
6 mg/m² i.v. bolus on day 1 and day 21
vincristine sulfate
1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29
radiation therapy
involved field irradiation, single daily fractions 1,5 Gy to max. 1,8 Gy standard dose 20 Gy, max dose 30 Gy (boost irradiation if required)
Interventions
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cyclophosphamide
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
doxorubicin hydrochloride
25mg/m²/day, 2 hours i.v.infusion on day 21
etoposide
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
prednisone
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
vinblastine sulfate
6 mg/m² i.v. bolus on day 1 and day 21
vincristine sulfate
1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29
radiation therapy
involved field irradiation, single daily fractions 1,5 Gy to max. 1,8 Gy standard dose 20 Gy, max dose 30 Gy (boost irradiation if required)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of classic Hodgkin's lymphoma (HL)
* Intermediate or advanced disease (stage I\[E\]-IV)
* No lymphocyte-predominant HL
* Previously untreated disease
PATIENT CHARACTERISTICS:
* Male
* No known hypersensitivity or contraindication to study drugs
* No other concurrent malignancies
* No severe concurrent diseases (e.g., immune deficiency syndrome)
* No known HIV positivity
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy or radiotherapy
* More than 30 days since prior and no other concurrent investigational drugs
* More than 30 days since prior and no concurrent participation in another clinical trial
18 Years
MALE
No
Sponsors
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Martin-Luther-Universität Halle-Wittenberg
OTHER
Christine Mauz-Körholz
OTHER
Responsible Party
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Christine Mauz-Körholz
Study Secretary of the EuroNet-PHL group
Principal Investigators
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Dieter Koerholz, MD
Role: STUDY_CHAIR
Martin-Luther-Universität Halle-Wittenberg
Locations
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Klinikum Augsburg
Augsburg, , Germany
Charite University Medical Center of Berlin
Berlin, , Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Universitaets - Kinderklinik
Erlangen, , Germany
Universitaetsfrauenklinik Frankfurt
Frankfurt, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaets - Kinderklinik
Leipzig, , Germany
Kinderklinik d. TU / Schwabing
Munich, , Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
University Children's Hospital
Zurich, , Switzerland
Countries
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Other Identifiers
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GPOH-HD-2002-PILOT-VECOPA
Identifier Type: -
Identifier Source: secondary_id
EU-20652
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2004-005244-28
Identifier Type: -
Identifier Source: secondary_id
CDR0000514344
Identifier Type: -
Identifier Source: org_study_id
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