Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more cancer cells.
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.
Drug: doxorubicin hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA|
- Toxicity at days 21 and 42 (+/- 2 days) of treatment [ Time Frame: days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle ] [ Designated as safety issue: Yes ]number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery
- Event-free survival [ Time Frame: event-free survival at 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: overall survival at 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||March 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
dose and time intensified consoloditation chemotherapy cycle
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21Drug: doxorubicin hydrochloride
25mg/m²/day, 2 hours i.v.infusion on day 21Drug: etoposide
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3Drug: prednisone
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34Drug: vinblastine sulfate
6 mg/m² i.v. bolus on day 1 and day 21Drug: vincristine sulfate
1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29Radiation: 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398554
|Augsburg, Germany, D-86156|
|Charite University Medical Center of Berlin|
|Berlin, Germany, D-13347|
|Medizinische Universitaetsklinik I at the University of Cologne|
|Cologne, Germany, D-50924|
|Universitaets - Kinderklinik|
|Erlangen, Germany, 91054|
|Frankfurt, Germany, D-60596|
|Halle, Germany, D-06097|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Universitaets - Kinderklinik|
|Leipzig, Germany, D-04317|
|Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster|
|Muenster, Germany, D-48149|
|Kinderklinik d. TU / Schwabing|
|Munich, Germany, 80804|
|Oldenburg, Germany, D-26133|
|University Children's Hospital|
|Zurich, Switzerland, CH-8032|
|Study Chair:||Dieter Koerholz, MD||Martin-Luther-Universität Halle-Wittenberg|