Back to resultsA Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
Primary Purpose
Brain Cancer, Head and Neck Cancer, Cervix Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Velcade (bortezomib)
Sponsored by
About this trial
This is an interventional treatment trial for Brain Cancer focused on measuring Malignancies of the central nervous system, head and neck area, and cervix
Eligibility 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
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CNS
Head and Neck
Cervix
Arm Description
Velcade (bortezomib)
Velcade (bortezomib)
Velcade (bortezomib)
Outcomes
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
Full Information
NCT ID
NCT00329589
First Posted
May 24, 2006
Last Updated
May 5, 2017
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00329589
Brief Title
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Millennium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Head and Neck Cancer, Cervix Cancer, Central Nervous System Neoplasms
Keywords
Malignancies of the central nervous system, head and neck area, and cervix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNS
Arm Type
Experimental
Arm Description
Velcade (bortezomib)
Arm Title
Head and Neck
Arm Type
Experimental
Arm Description
Velcade (bortezomib)
Arm Title
Cervix
Arm Type
Experimental
Arm Description
Velcade (bortezomib)
Intervention Type
Drug
Intervention Name(s)
Velcade (bortezomib)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Dicker, MD, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
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