A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients

This study is currently recruiting participants.

Verified by Thomas Jefferson University, September 2006

Sponsors and Collaborators:	Thomas Jefferson University Millennium Pharmaceuticals, Inc.
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00329589

Purpose

The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

Condition	Intervention	Phase
Brain Cancer Head and Neck Cancer Cervix Cancer Central Nervous System Neoplasms	Drug: Velcade (bortezomib)	Phase I

MedlinePlus related topics: Brain Cancer Cancer Cervical Cancer Head and Neck Cancer

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Open-Labeled, Dose-Escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy

Secondary Outcome Measures:

To evaluate tumor response

Estimated Enrollment:	54
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2008

Detailed Description:

To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
To evaluate tumor response

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed malignancy
Requiring at least grade 2 weeks of radiation therapy
Solid tumors of the central nervous system, head and neck area, and cervix
World Health Organization (WHO) performance status equal to or less than 2

Exclusion Criteria:

Equal to or greater than grade 2 peripheral neuropathy
Myocardial infarction within 6 months
Hypersensitivity to bortezomib, boron, or mannitol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329589

Contacts

Contact: Adam Dicker, MD, PhD	215-955-6527	adam.dicker@mail.tju.edu
Contact: Gayle Mallon, CCRP	215-955-8619	gayle.mallon@mail.tju.edu

Locations

United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Adam Dicker, MD, PhD 215-955-6527 adam.dicker@mail.tju.edu
Contact: Rita Axelrod, MD 215-955-8874 rita.axelrod@jefferson.edu
Principal Investigator: Adam Dicker, MD, PhD

Sponsors and Collaborators

Thomas Jefferson University

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Adam Dicker, MD, PhD

Thomas Jefferson University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	05C.255
Study First Received:	May 24, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00329589
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

Malignancies of the central nervous system, head and neck area
and cervix

Study placed in the following topic categories:

Bortezomib
Genital Neoplasms, Female
Central Nervous System Diseases
Uterine Diseases
Urogenital Neoplasms
Central Nervous System Neoplasms
Brain Diseases

Uterine Cervical Neoplasms
Genital Diseases, Female
Brain Neoplasms
Uterine Cervical Diseases
Head and Neck Neoplasms
Uterine Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009