Skip to main content
OpenTrials
Completed

NCT Number: NCT00398554

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Klinikum Augsburg, Augsburg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21

Doxorubicin hydrochloride

Drug

25mg/m²/day, 2 hours i.v.infusion on day 21

etoposide

Drug

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

Prednisone

Drug

40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34

vinblastine sulfate

Drug

6 mg/m² i.v. bolus on day 1 and day 21

vincristine sulfate

Drug

1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29

radiation therapy

Radiation

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 outcomes

  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 outcomes

  1. Event-free survival

    Time frame: event-free survival at 5 years

  2. Overall survival

    Time frame: overall survival at 5 years

Sponsors and collaborators

Lead sponsor

Christine Mauz-Körholz

Other

Collaborators

  • Martin-Luther-Universität Halle-Wittenberg

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2012
Study completion
2013
First posted
Nov 10, 2006
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.