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

March 24, 2020 updated by: Christine Mauz-Körholz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, D-86156
        • Klinikum Augsburg
      • Berlin, Germany, D-13347
        • Charite University Medical Center of Berlin
      • Cologne, Germany, D-50924
        • Medizinische Universitaetsklinik I at the University of Cologne
      • Erlangen, Germany, 91054
        • Universitaets - Kinderklinik
      • Frankfurt, Germany, D-60596
        • Universitaetsfrauenklinik Frankfurt
      • Halle, Germany, D-06097
        • Universitaetsklinikum Halle
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, D-04317
        • Universitaets - Kinderklinik
      • Muenster, Germany, D-48149
        • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
      • Munich, Germany, 80804
        • Kinderklinik d. TU / Schwabing
      • Oldenburg, Germany, D-26133
        • Klinikum Oldenburg
  • Switzerland
      • Zurich, Switzerland, CH-8032
        • University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Event-free survival
Time Frame: event-free survival at 5 years
event-free survival at 5 years
Overall survival
Time Frame: overall survival at 5 years
overall survival at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine Mauz-Körholz

Collaborators

Martin-Luther-Universität Halle-Wittenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000514344
  • GPOH-HD-2002-PILOT-VECOPA
  • EU-20652
  • EUDRACT-2004-005244-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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