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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT00329589
Collaborator
Millennium Pharmaceuticals, Inc. (Industry)
54
Enrollment
1
Location
3
Arms
57
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Velcade (bortezomib)
 Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
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
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: CNS

Velcade (bortezomib)

Drug: Velcade (bortezomib)
Experimental: Head and Neck

Velcade (bortezomib)

Drug: Velcade (bortezomib)
Experimental: Cervix

Velcade (bortezomib)

Drug: Velcade (bortezomib)

Outcome Measures

Primary Outcome Measures

  1. 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 [2-8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329589
Other Study ID Numbers:
  • 05C.255
  • 2005-28
  • NCI-2009-01797
First Posted:
May 25, 2006
Last Update Posted:
May 9, 2017
Last Verified:
May 1, 2017
Keywords provided by Sidney Kimmel Cancer Center at Thomas Jefferson University
Malignancies of the central nervous system, head and neck area
and cervix
Additional relevant MeSH terms:
Brain Neoplasms
Uterine Cervical Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Bortezomib

Study Results

No Results Posted as of May 9, 2017