Intratumoral Ipilimumab in Head and Neck Cancer

Who is this study for? Adult patients with Head and Neck Squamous Cell Carcinoma that plan to undergo surgical resection
What treatments are being studied? Ipilimumab
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This study will test the feasibility of the administration of intratumoral injections of ipilimumab prior to surgical resection, and the immune system response to treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with SCCHN who are planned for surgical resection and in the opinion of the surgeon are able to safely undergo tissue biopsy plus intratumoral (IT) injection in advance, with special consideration given to risk of occlusion or compression of airway or major vessels in the neck, secondary to tumor swelling, or erosion into a major vessel in the case of necrosis.

• Age 18 years or above with ability to give informed consent, comply with the protocol and sign a study-specific consent document. Patients with history of psychiatric illness must be judged by the investigator as able to understand the investigational nature and risks associated with the therapy.

• Any Eastern Cooperative Oncology Group (ECOG) performance status deemed suitable by investigator for requirements of study, to potentially include incisional office biopsy of lesion, or image guided multiple 18g core needle biopsies (5 minimum) by interventional radiology, followed immediately by direct injection of lesion with drug.

• Patients must have blood test results within protocol-specified parameters

• Men must agree to not attempt to become a new father for a total of 165 days post-treatment completion

• Women must agree not to become pregnant for a total of 105 days post treatment completion

Locations
United States
Oregon
Portland Providence Medical Center
Portland
Time Frame
Start Date: 2016-11-18
Completion Date: 2024-12
Participants
Target number of participants: 18
Treatments
Experimental: Intratumoral Ipilimumab
Patients receive a 3mg intratumoral injection of ipilimumab during a biopsy procedure.
Sponsors
Leads: Providence Health & Services
Collaborators: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov

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