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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Adam Dicker, MD, PhD
Principal Investigator
Thomas Jefferson University
United States: Institutional Review Board
05C.255
NCT00329589
September 2005
June 2010
Name | Location |
---|---|
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |