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Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma

NCT00439361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-07-09

No results posted yet for this study

Summary

Primary Objectives:

1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
2. To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin lymphoma (HL).

Secondary Objectives:

\- To determine the overall response rate and complete response rate in patients with relapsed and refractory classical Hodgkin lymphoma (HL).

Conditions

Interventions

DRUG

Bortezomib

1.0 mg/m\^2 by Vein Over 5 Seconds on Days 1 and 4

DRUG

Carboplatin

5 AUC by Vein Over 1 Hour On Day 1

DRUG

Etoposide

100 mg/m\^2 By Vein Over 2 Hours On Days 1-3

DRUG

Ifosfamide

5 Gm/m\^2 By Vein Continuous Infusion Over 24 Hours On Day 1

DRUG

Mesna

5 mg/m\^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m\^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Michelle A. Fanale, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439361 on ClinicalTrials.gov