Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy

Recurrent Adult Hodgkin Lymphoma Clinical Trial

Official title: A Phase II Study of Bortezomib (Velcade, PS-341) in Combination With Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults With Refractory/Recurrent Hodgkin Disease

Status Completed

Clinical Trial Summary

This phase II trial studies the side effects and efficacy of bortezomib with ifosfamide and vinorelbine in children and young adults with Hodgkin's lymphoma that was recurrent or did not respond to previous therapy. Bortezomib is an inhibitor of protein degradation. Bortezomib degrades short-lived regulatory proteins in the cell, and has been reported to increase the tumor cells. Bortezomib may increase the effectiveness of ifosfamide and vinorelbine (two standard drugs given to children with Hodgkin Lymphoma that has come back after initial treatment) by making cancer cells more sensitive to effectiveness of standard chemotherapy by preventing anti-death responses in these drugs. Giving bortezomib together with ifosfamide and vinorelbine tartrate should kill more cancer cells than are killed with ifosfamide and vinorelbine alone.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the efficacy and safety of bortezomib (as a chemosensitizing agent) in pediatric patients and young adults with primary refractory Hodgkin's lymphoma (HL) or HL in first relapse.

II. Determine the response rate in patients treated with bortezomib, ifosfamide, and vinorelbine ditartrate (vinorelbine tartrate) (IVB) and compare the response rate to the historical response rate in patients treated with ifosfamide and vinorelbine ditartrate alone.

SECONDARY OBJECTIVES:

I. Determine the overall response rate (complete and partial response) and induction success rate after 2 or 4 courses of therapy and the reinduction rate (complete response) after 4 courses of therapy.

II. Determine the proportion of patients able to mobilize sufficient hematopoietic stem cells (CD34+) after 2 courses of IVB.

OUTLINE: This is a multicenter, open-label, pilot study.

Patients receive ifosfamide intravenously (IV) continuously over days 1-4, vinorelbine tartrate IV over 6-10 minutes on days 1 and 5, and bortezomib intravenously on days 1, 4, and 8, and filgrastim (G-CSF) by vein or subcutaneously beginning on day 6 and continuing until blood counts recover or peripheral blood stem cells (PBSC) are harvested. Treatment cycles repeat every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually thereafter. ;

Related Conditions & MeSH terms

• Adult Lymphocyte Depletion Hodgkin Lymphoma
• Adult Lymphocyte Predominant Hodgkin Lymphoma
• Adult Mixed Cellularity Hodgkin Lymphoma
• Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
• Adult Nodular Sclerosis Hodgkin Lymphoma
• Childhood Lymphocyte Depletion Hodgkin Lymphoma
• Childhood Lymphocyte Predominant Hodgkin Lymphoma
• Childhood Mixed Cellularity Hodgkin Lymphoma
• Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
• Childhood Nodular Sclerosis Hodgkin Lymphoma
• Hodgkin Disease
• Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Recurrent/Refractory Childhood Hodgkin Lymphoma
• Sclerosis
• Stage I Adult Hodgkin Lymphoma
• Stage I Childhood Hodgkin Lymphoma
• Stage II Adult Hodgkin Lymphoma
• Stage II Childhood Hodgkin Lymphoma
• Stage III Adult Hodgkin Lymphoma
• Stage III Childhood Hodgkin Lymphoma
• Stage IV Adult Hodgkin Lymphoma
• Stage IV Childhood Hodgkin Lymphoma

• NCT number: NCT00381940
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: January 2007
• Completion date: December 31, 2016