A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
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.
Biological: bleomycin sulfate
Drug: mitoxantrone hydrochloride
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Disease-free survival by routine imaging [ Time Frame: 6 month intervals ] [ Designated as safety issue: No ]
- Overall survival by routine imaging [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment
Treatment with VEPEMB - Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin.
|Biological: bleomycin sulfate Drug: cyclophosphamide Drug: etoposide Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: procarbazine hydrochloride Drug: vinblastine sulfate|
No Intervention: Registration
Registration, without treatment
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079105
Show 54 Study Locations
|Study Chair:||Stephen J. Proctor, MD, FRCP, FRCPath||University of Newcastle Upon-Tyne|
|Study Director:||Helen H. Lucraft, MD||Northern Centre for Cancer Treatment at Newcastle General Hospital|
|Study Director:||Katrina M. Wood, MD||Sir James Spence Institute of Child Health at Royal Victoria Infirmary|