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
N/A
18 Years
Male
Lymphoma
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity at days 21 and 42 (+/- 2 days) of treatment
Outcome Description:
number of VECOPA cycles that allow continuation of chemotherapy on a sufficient hematopoietic recovery
Outcome Time Frame:
days 21 and 42 (+/- 2 days) of treatment after start of VECOPA cycle
Safety Issue:
Yes
Principal Investigator
Dieter Koerholz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Martin-Luther-Universität Halle-Wittenberg
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CDR0000514344
NCT ID:
NCT00398554
Start Date:
June 2005
Completion Date:
March 2013
Related Keywords:
- Lymphoma
- 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
- Hodgkin Disease
- Lymphoma
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