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

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.

Conditions

• 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
• Recurrent Adult Hodgkin Lymphoma
• Recurrent/Refractory Childhood Hodgkin Lymphoma
• 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

Interventions

DRUG

ifosfamide

Given IV

DRUG

bortezomib

Given IV

DRUG

vinorelbine tartrate

Given IV

BIOLOGICAL

filgrastim

Given IV or SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Terzah Horton · Children's Oncology Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2008-06-30

Completion

2016-12-31

Countries

• United States

Study Locations