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


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain Cancer, Head and Neck Cancer, Cervix Cancer, Central Nervous System Neoplasms

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Trial Information

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


- To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of
VelcadeĀ® 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 VelcadeĀ® 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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safe and maximum tolerated dose of VelcadeĀ® 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

Principal Investigator

Adam Dicker, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Institutional Review Board

Study ID:

05C.255

NCT ID:

NCT00329589

Start Date:

September 2005

Completion Date:

June 2010

Related Keywords:

  • Brain Cancer
  • Head and Neck Cancer
  • Cervix Cancer
  • Central Nervous System Neoplasms
  • Malignancies of the central nervous system, head and neck area
  • and cervix
  • Brain Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Head and Neck Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131