NCT00079105

A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 60 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate	Treatment
DRUG	cyclophosphamide	Treatment
DRUG	etoposide	Treatment
DRUG	mitoxantrone hydrochloride	Treatment
DRUG	prednisolone	Treatment
DRUG	procarbazine hydrochloride	Treatment
DRUG	vinblastine sulfate	Treatment

Timeline

• Start date: 2004-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2004-03-09
• Last updated: 2017-03-30

Locations

54 sites across 2 countries: Germany, United Kingdom