Lymphoma
Conditions
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
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.
Interventions
DRUGcyclophosphamide
1250 mg/m2 i.v. 60 Min.-Inf. day 1 and 21
DRUGdoxorubicin hydrochloride
25mg/m²/day, 2 hours i.v.infusion on day 21
DRUGetoposide
150 mg/m²/day, 2 hours i.v.infusion (intravenous drip) on days 1 - 3
DRUGprednisone
40 mg/m2/day p.o. (intake by mouth)divided in 3 single doses daily from day 1 - 14 and day 21 - 34
DRUGvinblastine sulfate
6 mg/m² i.v. bolus on day 1 and day 21
DRUGvincristine sulfate
1,5 mg/m2 i.v. bolus max. single dose 2 mg (cap dose at 2 mg) on day 8 and day 29
RADIATIONradiation 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)
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Christine Mauz-Körholz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Event-free survival | event-free survival at 5 years |
| Overall survival | overall survival at 5 years |
Countries
Germany, Switzerland
Outcome results
None listed