Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00398554|
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : November 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||March 2013|
dose and time intensified consoloditation chemotherapy cycle
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
Drug: doxorubicin hydrochloride
25mg/m²/day, 2 hours i.v.infusion on day 21
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
Drug: vinblastine sulfate
6 mg/m² i.v. bolus on day 1 and day 21
Drug: 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: 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)
- 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 ]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 ]
- Overall survival [ Time Frame: overall survival at 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|