Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398554
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : November 18, 2015
Martin-Luther-Universität Halle-Wittenberg
Information provided by (Responsible Party):
Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg

Brief Summary:

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

Detailed Description:


  • 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)
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
Study Start Date : June 2005
Actual Primary Completion Date : October 2012
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: VECOPA
dose and time intensified consoloditation chemotherapy cycle
Drug: cyclophosphamide
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

Drug: etoposide
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3

Drug: prednisone
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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Event-free survival [ Time Frame: event-free survival at 5 years ]
  2. Overall survival [ Time Frame: overall survival at 5 years ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of classic Hodgkin's lymphoma (HL)

    • Intermediate or advanced disease (stage I[E]-IV)
  • No lymphocyte-predominant HL
  • Previously untreated disease


  • 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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00398554

Klinikum Augsburg
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
Universitaetsfrauenklinik Frankfurt
Frankfurt, Germany, D-60596
Universitaetsklinikum Halle
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
Klinikum Oldenburg
Oldenburg, Germany, D-26133
University Children's Hospital
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
Christine Mauz-Körholz
Martin-Luther-Universität Halle-Wittenberg
Study Chair: Dieter Koerholz, MD Martin-Luther-Universität Halle-Wittenberg

Responsible Party: Christine Mauz-Körholz, Study Secretary of the EuroNet-PHL group, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT00398554     History of Changes
Other Study ID Numbers: CDR0000514344
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg:
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
childhood lymphocyte depletion Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
childhood nodular sclerosis Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents