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Ph II CHOP+Velcade in Mediastinal LBCL

NCT00361621 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2012-12-03

No results posted yet for this study

Summary

The main purpose of this study is to begin to collect information and try to learn whether or not VELCADE, when added to standard chemotherapy with CHOP/Rituxan, works in treating patients mediastinal large B-cell lymphoma. Recent research has shown that this type of lymphoma shares features with Hodgkin's lymphoma, including the importance of a particular pathway in the tumor cells called the NF-kB pathway. VELCADE works in part by blocking this pathway.

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

DRUG

bortezomib

Given intravenously on day 1 and day 4 of a 21-day cycle for 6 cycles

DRUG

Rituximab

Given intravenously on day 1 of a 21-day cycle for 6 cycles

DRUG

Cyclophosphamide

Given intravenously on day 1 of a 21-day cycle for 6 cycles

DRUG

Doxorubicin

Given intravenously on day 1 of a 21-day cycle for 6 cycles

DRUG

Vincristine

Given intravenously on day 1 of a 21-day cycle for 6 cycles

DRUG

Prednisone

Taken orally on days 2, 3, 4 and 5 or a 21-day cycle for 6 cycles

RADIATION

Radiation therapy

After 6 cycles of chemotherapy there will be 3 weeks of radiation therapy

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Ann LaCasce, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-11-30
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT00361621 on ClinicalTrials.gov