Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer
This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer: a Rational Anti-Cancer Stem Cell Combination.|
- Dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab [ Time Frame: The first 3 patients enrolled will receive the first dose level. A full safety evaluation will be conducted after 6 weeks of therapy. This will continue until a MTD is determined. ] [ Designated as safety issue: Yes ]Cohorts of 3. The first cohort will receive dose level 1. A full safety evaluation will be conducted after 6 weeks. If 0/3 have a Dose limiting toxicity (DLT), then a new cohort will receive the next dose level. If 1/3 have DLT then 3 more patients will be treated at this dose level. If none has DLT then the next dose level will be administered to the next cohort; otherwise the inferior dose level will be considered the maximum tolerated dose (MTD). If 2/3 have a DLT, then the inferior dose level will be considered the MTD. In the event that the initial dose level 1 is not tolerated, a level -1 has been defined for assessment.
- Evaluate the clinical activity of the combination of IPI-926 with cetuximab [ Time Frame: Patients will continue to receive treatment as long as there is evidence that their tumor is not growing and they are not experiencing any unacceptable side effects. ] [ Designated as safety issue: Yes ]Obtaining tumor biopsies at baseline, after 2 weeks of cetuximab, and after 3-4 weeks of dual therapy will enable testing our hypotheses. Patients will be assessed by standard criteria. CTs will also be conducted at the end of first cycle to assess disease progression. Confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [The Journal of the National Cancer Institute (JNCI) 92(3):205-216, 2000].
|Study Start Date:||April 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: IPI-926 and Cetuximab
Drug: IPI-926 and Cetuximab
Other Name: brand name: ERBITUX
The purpose of this study is to determine the dose-limiting toxicities and the recommended dose for phase 2 evaluation of the combination of IPI-926 and cetuximab in patients with advanced head and neck cancer.
|United States, Colorado|
|University of Colorado Denver|
|Denver, Colorado, United States, 80045|
|Principal Investigator:||Antonio Jimeno, MD, PhD||University of Colorado, Denver|