Ipilimumab for Head and Neck Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02812524|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Intratumoral Ipilimumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intratumoral Ipilimumab in Head and Neck Cancer|
|Actual Study Start Date :||November 18, 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Experimental: Intratumoral Ipilimumab
Patients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.
Drug: Intratumoral Ipilimumab
Patients with a planned resection of SCCHN will have a biopsy procedure 7-10 days prior to surgery and receive an injection of ipilimumab directly into a tumor.
- Surgery delay [ Time Frame: 7-10 Days ]The percentage of patients with surgery delayed possibly related to the study drug.
- Feasibility of paired tissue sample acquisition [ Time Frame: 7-10 Days ]The number of tissue samples that can be collected which were: biopsied, injected, and resected.
- Acceptance of study [ Time Frame: 28 Days ]The screening-to-enrollment ratio will be calculated.
- Failure rate of planned laboratory assays [ Time Frame: 7-10 days ]The percentage of assays achieving a result.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812524
|Contact: Rom S. Leidner, MD||503-215-5696||Rom.Leidner@Providence.org|
|Contact: R. Bryan Bell, MD, DDS||(503) 215-3053||Richard.Bell@Providence.org|
|United States, Oregon|
|Portland Providence Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Brenda Fisher, RN 503-215-2613 Brenda.Fisher@providence.org|
|Sub-Investigator: Brendan Curti, MD|
|Sub-Investigator: Todd Crocenzi, MD|
|Sub-Investigator: Rachel Sanborn, MD|
|Sub-Investigator: Walter J. Urba, MD, PhD|
|Sub-Investigator: Alison Conlin, MD|
|Sub-Investigator: John Godwin, MD|
|Principal Investigator: Rom Leidner, MD|
|Sub-Investigator: Rui Li, MD, PhD|
|Principal Investigator: Richard B. Bell, MD, DDS|
|Sub-Investigator: David Page, MD|
|Principal Investigator:||Rom S Leidner, MD||Providence Health & Services|
|Principal Investigator:||R. Bryan Bell, MD, DDS||Providence Health & Services|