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

• 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
  
  

• 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 ]
  

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)

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.