Chemo-Emboli zation for Head and Neck Cancer

Overseen by Jesse Jones, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jesse Jones, MD

Principal Investigator

The University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 with squamous cell carcinoma of the head and neck who can't use cisplatin due to certain health issues like kidney, nerve, or ear problems. They must be able to have chemo-embolization, follow study rules, and plan standard cancer treatments. Pregnant women and those unfit for the procedure are excluded.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with squamous cell carcinoma in my head or neck.

I cannot receive platinum-based chemotherapy due to kidney, nerve, or ear problems, or because my physical health status is limited.

Exclusion Criteria

You are already participating in a clinical trial that doesn't allow adjuvant chemo-embolization or taking another investigational drug.

I cannot undergo chemo-embolization due to my health condition.

Treatment Details

Interventions

• Cisplatin (Alkylating agents)

Trial Overview The study tests if adding chemo-embolization to usual cancer care (radiation plus chemotherapy/immunotherapy) helps patients live longer without their cancer getting worse compared to just standard care in those who cannot tolerate cisplatin.

Participant Groups

Group I: Chemo-embolization Experimental Treatment 1 Intervention

Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham