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Chemo-embolization for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT04595981
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Jesse G. A. Jones, MD, University of Alabama at Birmingham

Study Description
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Brief Summary:
The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

Condition or disease Intervention/treatment Phase
SCCHN Squamous Cell Carcinoma Drug: Cisplatin Phase 2

Detailed Description:
This is a single site, single arm Phase II trial pilot study to explore if chemo-embolization increases progression free and/or overall survival in a subpopulation of cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate in the U.S. Chemo-embolization will serve as adjuvant therapy performed in addition to standard of care radiation and chemo- and/or immunotherapy. Within UAB, the Investigators plan to recruit 48 patients to implement the intervention, within a two-year period. Progression free survival will be assessed at 3, 6 and 24 months (if available) after intervention, which is determined based upon the results of follow-up Head and Neck imaging (CT or MRI) interpreted by a Radiologist not involved in the study, per standard of care. Overall survival will be reported by the patients' Oncology team on a monthly basis. The trial endpoints will form the basis of how PFS and OS compare to historical outcomes in a similar cohort of patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemo-embolization for Head and Neck Cancer
Estimated Study Start Date : May 2025
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chemo-embolization
Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)
 Drug: Cisplatin
Subjects will be admitted to the UAB Heart and Vascular Center, pre-medicated with 24 mg Ondansetron IV, 500 mg Prednisolone IV and 1.5 L NaCl with 20 meq KCl IV. The chemo-embolic agent is prepared in the HVC pharmacy by reconstituting 300 mg lyophilized Cisplatin in 60 mL 0.9% NaCl. Subjects are placed under anesthesia in the angiography suite. The access site is prepped and draped in sterile fashion then the femoral artery is catheterized using a 5-French catheter containing a coaxial microcatheter. After superselective visualization of the tumor-feeding vessel, a microcatheter is advanced into the target vessel and infused with 150 mg m2 cisplatin in 45-60 mL NaCl over 30-60 seconds. 10 seconds after the infusion starts, 9 gm sodium thiosulphate is administered IV to neutralize systemic Cisplatin. A post-infusion angiogram is then performed to assess the adequacy of embolization. The catheter is removed and the arteriotomy site closed with a subcutaneous suture.
Other Name: Platinol


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate progression free survival [ Time Frame: 6 Months ]
    Progression free survival is the length of time from the day of the chemo-embolization procedure that a patient lives with the disease but it does not get worse. Cumulative progression-free survival for all patients will be calculated by the Kaplan-Meier method, including the point estimates of progression-free survival and the 95% confidence intervals, evaluated during a six-month period of follow-up.


Secondary Outcome Measures :
  1. Evaluate overall survival [ Time Frame: 2 Years ]
    Although the overall survival is related to the primary endpoint (progression free survival), it will be measured independent of the progression free survival. Overall survival is defined for all patients and measured from time of treatment to death or end of a study.

  2. Evaluate oropharyngeal bleeding [ Time Frame: 2 years ]
    Physician visits prompted by new oropharyngeal bleeding that occurs after chemo-embolization will be tabulated. Cumulative bleed-free survival for all patients will be calculated by the Kaplan-Meier method, including the point estimates of bleed-free survival and the 95% confidence intervals, evaluated during a six-month period of follow-up.


Eligibility Criteria
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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:

  • 1. Provision of signed and dated informed consent form
  • 2.Stated willingness to comply with all study procedures and availability for the duration of the study
  • 3.Male or female, aged 18 or older
  • 4.Diagnosed with squamous cell carcinoma of the Head and Neck
  • 5.Ability to undergo chemo-embolization
  • 6.For females of reproductive potential: Negative pregnancy test at time of chemo-embolization
  • 7.Platinum-ineligible as determined by presence of CTS grade I nephropathy, neuropathy or otopathy, and/or ECOG 2+ performance status.
  • 8.Plan to undergo standard of care radiation and chemo- and/or immunotherapy.

Exclusion Criteria:

  • 1. Medically unfit to undergo chemo-embolization
  • 2. Treatment with a competing investigational drug or intervention trial that does not allow adjuvant chemo-embolization.
Contacts and Locations
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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): NCT04595981


Contacts
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Contact: Jesse Jones, MD 205-934-7170 jessejones@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jesse Jones, MD The University of Alabama at Birmingham
More Information
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Responsible Party: Jesse G. A. Jones, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04595981    
Other Study ID Numbers: IRB-300006231
UAB ( Other Identifier: UAB )
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jesse G. A. Jones, MD, University of Alabama at Birmingham:
Chemo-embolization
Chemoembolization
Squamous Cell Carcinoma of Head and Neck
SCCHN
Platinum-ineligible
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antineoplastic Agents