A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
OBJECTIVES:
Primary
- Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine,
prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's
lymphoma.
- Determine whether the application of the Hasenclever prognostic index is valid in these
patients at diagnosis.
OUTLINE: This is an open-label, multicenter study.
- Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral
procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and
mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the
absence of disease progression or unacceptable toxicity, for a total of 3 courses in
patients with early (stage IA or IIA) disease or 6 courses in patients with advanced
(stage IB or IIB-IV) disease.
- Radiotherapy: Patients with early stage disease receive involved-field radiotherapy.
Patients with advanced stage disease receive radiotherapy limited to sites of initial
bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of
chemotherapy.
Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually
thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Disease-free survival by routine imaging at 6 month intervals
No
Stephen J. Proctor, MD, FRCP, FRCPath
Study Chair
University of Newcastle Upon-Tyne
Unspecified
CDR0000354225
NCT00079105
January 2004
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