Clinical trial NCT00398554: Combination Chemotherapy in Treating Young Male Patients With Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
First posted: 2006-11-10
Enrollment: 16
Sex: MALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Toxicity at days 21 and 42 (+/- 2 days) of treatment
timeFrame: days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle
Secondary outcomes:
measure: Event-free survival
timeFrame: event-free survival at 5 years
measure: Overall survival
timeFrame: overall survival at 5 years
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charite University Medical Center of Berlin
city: Cologne
country: Germany
facility: Medizinische Universitaetsklinik I at the University of Cologne
city: Erlangen
country: Germany
facility: Universitaets - Kinderklinik
city: Frankfurt
country: Germany
facility: Universitaetsfrauenklinik Frankfurt
city: Halle
country: Germany
facility: Universitaetsklinikum Halle
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Universitaets - Kinderklinik
city: Muenster
country: Germany
facility: Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
city: Munich
country: Germany
facility: Kinderklinik d. TU / Schwabing
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Zurich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: Martin-Luther-Universität Halle-Wittenberg
name: Dieter Koerholz, MD
role: STUDY_CHAIR
References: