CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
ifosfamide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00381940
NCT00381940Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Sep 28, 2006·Updated Mar 24, 2021

In Brief

A Phase 2 clinical trial evaluating ifosfamide, bortezomib, and 2 other interventions for Adult Lymphocyte Depletion Hodgkin Lymphoma and 19 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2006
Enrollment StartJan 1, 2007
Primary CompletionJun 1, 2008
Study CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.8 years ago

Interventions

ifosfamidedrug

Given IV

bortezomibdrug

Given IV

vinorelbine tartratedrug

Given IV

filgrastimbiological

Given IV or SC