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

May 5, 2017 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Adam Dicker, MD, PhD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 25, 2006

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05C.255
  • 2005-28 (Other Identifier: CCRRC)
  • NCI-2009-01797 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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