Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: September 2009

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.

Intervention(s) in this Clinical Trial

• Drug: bleomycin
• Drug: cyclophosphamide
• Drug: etoposide
• Drug: mitoxantrone hydrochloride
• Drug: prednisolone
• Drug: procarbazine hydrochloride
• Drug: vinblastine

Primary Measures

• Disease-free survival by routine imaging at 6 month intervals
  • Safety Issue?: No

Secondary Measures

• Overall survival by routine imaging at 5 years
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Histologically confirmed classical Hodgkin's lymphoma
• Previously untreated disease
• No nodular lymphocyte predominant Hodgkin's lymphoma

PATIENT CHARACTERISTICS:

• Age
• Over 60
• Performance status
• Not specified
• Life expectancy
• Not specified
• Hematopoietic
• Not specified
• Hepatic
• No significant hepatic abnormality that would preclude study participation
• Renal
• No significant renal abnormality that would preclude study participation
• Cardiovascular
• No significant cardiac abnormality that would preclude study participation
• Pulmonary
• No significant pulmonary abnormality that would preclude study participation
• Other
• "Non-fragile" status (i.e., mental and physical status must be sufficient to withstand study therapy)
• HIV negative
• No other concurrent neoplasia

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• Not specified
• Radiotherapy
• Not specified
• Surgery
• Not specified

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Newcastle Upon-Tyne

Overall Clinical Trial Officials and Contacts

Stephen J. Proctor, MD, FRCP, FRCPath Study Chair University of Newcastle Upon-Tyne  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00079105

Study ID Number: CDR0000354225

ClinicalTrials.gov Identifier: NCT00079105

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database