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

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Biological: bleomycin sulfate; Drug: cyclophosphamide; Drug: etoposide; Drug: mitoxantrone hydrochloride; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vinblastine sulfate

• Registration Number: NCT00079105
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-03-08
• Study First Submitted QC: 2004-03-08
• Study First Posted: 2004-03-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	bleomycin sulfate	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Treatment	cyclophosphamide	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Treatment	etoposide	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Treatment	mitoxantrone hydrochloride	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Treatment	vinblastine sulfate	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Treatment	procarbazine hydrochloride	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Treatment	prednisolone	Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate

Primary Outcome Measures

Name	Time	Method
Disease-free survival by routine imaging	6 month intervals

Secondary Outcome Measures

Name	Time	Method
Overall survival by routine imaging	5 years

Trial Locations

Locations (54)

Medizinische Universitaetsklinik I at the University of Cologne; 🇩🇪 Cologne, Germany

Wansbeck General Hospital; 🇬🇧 Ashington, England, United Kingdom

Basingstoke and North Hampshire NHS Foundation Trust; 🇬🇧 Basingstoke, England, United Kingdom

Royal United Hospital; 🇬🇧 Bath, England, United Kingdom

Good Hope Hospital; 🇬🇧 Birmingham, England, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, England, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, England, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, England, United Kingdom

Kent and Canterbury Hospital; 🇬🇧 Canterbury, England, United Kingdom

Cumberland Infirmary; 🇬🇧 Carlisle, England, United Kingdom

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