Lymphoma Clinical Trial
Official title:
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine,
prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer
cells from dividing so they stop growing or die. Combining more than one chemotherapy drug
may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
older patients with previously untreated Hodgkin's lymphoma.
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.
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