Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment

Lymphoma Clinical Trial

Official title: A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma

Status Withdrawn

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with gemcitabine and vinorelbine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.

Clinical Trial Description

OBJECTIVES:

Primary

• Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine ditartrate.

Secondary

• Assess progression-free survival, failure-free survival, and overall survival of patients treated with this regimen.

• Characterize the safety profile of this regimen in these patients.

• Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in patients eligible for stem cell transplantation.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT).

• Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.

• Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed for at least 2 years. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

• NCT number: NCT00881387
• Study type: Interventional
• Source: University of Miami
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2009
• Completion date: October 2012