We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329589
First Posted: May 25, 2006
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at 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 [ Time Frame: 2-8 weeks ]

Enrollment: 54
Study Start Date: September 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNS
Velcade (bortezomib)
Drug: Velcade (bortezomib)
Experimental: Head and Neck
Velcade (bortezomib)
Drug: Velcade (bortezomib)
Experimental: Cervix
Velcade (bortezomib)
Drug: Velcade (bortezomib)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329589


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Adam Dicker, MD, PhD Thomas Jefferson University
  More Information

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00329589     History of Changes
Other Study ID Numbers: 05C.255
2005-28 ( Other Identifier: CCRRC )
NCI-2009-01797 ( Registry Identifier: NCI CTRP )
First Submitted: May 24, 2006
First Posted: May 25, 2006
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Malignancies of the central nervous system, head and neck area
and cervix

Additional relevant MeSH terms:
Head and Neck Neoplasms
Brain Neoplasms
Uterine Cervical Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Bortezomib
Antineoplastic Agents