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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Martin-Luther-Universität Halle-Wittenberg
Information provided by (Responsible Party):
Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00398554
First received: November 9, 2006
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisone
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2005
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398554

Locations
Germany
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
Switzerland
University Children's Hospital
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
Christine Mauz-Körholz
Martin-Luther-Universität Halle-Wittenberg
Investigators
Study Chair: Dieter Koerholz, MD Martin-Luther-Universität Halle-Wittenberg
  More Information

Additional Information:
No publications provided

Responsible Party: Christine Mauz-Körholz, Study Secretary of the EuroNet-PHL group, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00398554     History of Changes
Other Study ID Numbers: CDR0000514344, GPOH-HD-2002-PILOT-VECOPA, EU-20652, EUDRACT-2004-005244-28
Study First Received: November 9, 2006
Last Updated: June 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Etoposide
Prednisone
Vinblastine
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014