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

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329589
First received: May 24, 2006
Last updated: August 19, 2010
Last verified: August 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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)
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
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, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Adam Dicker, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00329589     History of Changes
Other Study ID Numbers: 05C.255, 2005-28, NCI-2009-01797
Study First Received: May 24, 2006
Last Updated: August 19, 2010
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

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

ClinicalTrials.gov processed this record on November 20, 2014