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

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vinblastine sulfate; Drug: vincristine sulfate; Radiation: radiation therapy

• Registration Number: NCT00398554
• Lead Sponsor: Christine Mauz-Körholz

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.

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Primary Completion: 2012-10
• Study Completion: 2013-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VECOPA	cyclophosphamide	dose and time intensified consoloditation chemotherapy cycle
VECOPA	etoposide	dose and time intensified consoloditation chemotherapy cycle
VECOPA	prednisone	dose and time intensified consoloditation chemotherapy cycle
VECOPA	vinblastine sulfate	dose and time intensified consoloditation chemotherapy cycle
VECOPA	vincristine sulfate	dose and time intensified consoloditation chemotherapy cycle
VECOPA	radiation therapy	dose and time intensified consoloditation chemotherapy cycle
VECOPA	doxorubicin hydrochloride	dose and time intensified consoloditation chemotherapy cycle

Primary Outcome Measures

Name	Time	Method
Toxicity at days 21 and 42 (+/- 2 days) of treatment	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

Name	Time	Method
Event-free survival	event-free survival at 5 years
Overall survival	overall survival at 5 years

Trial Locations

Locations (11)

University Children's Hospital; 🇨🇭 Zurich, Switzerland

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Universitaetsklinikum Halle; 🇩🇪 Halle, Germany

Medizinische Universitaetsklinik I at the University of Cologne; 🇩🇪 Cologne, Germany

Charite University Medical Center of Berlin; 🇩🇪 Berlin, Germany

Kinderklinik d. TU / Schwabing; 🇩🇪 Munich, Germany

Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster; 🇩🇪 Muenster, Germany

Universitaets - Kinderklinik; 🇩🇪 Leipzig, Germany

Universitaetsfrauenklinik Frankfurt; 🇩🇪 Frankfurt, Germany

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany