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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Providence Health & Services

Brief 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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Intratumoral Ipilimumab Phase 1

Detailed Description:
This study will test intratumor microdosing of ipilimumab (antagonistic antibody directed to Cytotoxic T-Lmphocyte-Associated Protein 4 [CTLA-4]) 7-10 days prior to planned surgical resection of tumor and involved lymph nodes in patients with SCCHN. Tissue, peripheral blood, saliva and stool samples will be obtained for immunologic end points. The primary objective is to assess safety, as determined by the number of surgeries that are delayed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Arm Intervention/treatment
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.
Other Names:
  • Yervoy
  • BMS734016
  • MDX-010




Primary Outcome Measures :
  1. Surgery delay [ Time Frame: 7-10 Days ]
    The percentage of patients with surgery delayed possibly related to the study drug.


Secondary Outcome Measures :
  1. 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.

  2. Acceptance of study [ Time Frame: 28 Days ]
    The screening-to-enrollment ratio will be calculated.


Other Outcome Measures:
  1. Failure rate of planned laboratory assays [ Time Frame: 7-10 days ]
    The percentage of assays achieving a result.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any clinical factors such as bleeding, active infection, colitis history or psychiatric factors that in the judgment of the investigator would preclude safe participation and compliance with study procedures.
  • Need for chronic maintenance oral steroids ≥ 20mg prednisone daily equivalent; inhaled steroids are acceptable.
  • History of or current active autoimmune diseases, [e.g. including but not limited to inflammatory bowel diseases (IBD), rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barre syndrome), which in the judgment of the investigator pose an active and significant risk. Vitiligo and adequately controlled endocrine deficiencies such as hypothyroidism are not exclusionary.]
  • Infectious diseases including human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and hepatitis C virus (HCV).
  • Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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         
Sponsors and Collaborators
Providence Health & Services
Bristol-Myers Squibb
Investigators
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Principal Investigator: Rom S Leidner, MD Providence Health & Services
Principal Investigator: R. Bryan Bell, MD, DDS Providence Health & Services
Additional Information:
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02812524    
Other Study ID Numbers: 16-042
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Providence Health & Services:
Immunotherapy
Yervoy
Head and neck cancer
Pre-operative
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents