Chemo-Emboli zation for Head and Neck Cancer

Overseen By Jesse Jones, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Medically unfit, Competing trial, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

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 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.

I am planning to receive standard radiation and either chemotherapy or immunotherapy.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant chemo-embolization in addition to standard of care radiation and chemo- and/or immunotherapy

6 months

Monthly visits for treatment and monitoring

Follow-up

Participants are monitored for progression free survival and overall survival

2 years

Regular imaging and oncology team assessments

Treatment Details

Interventions

• Cisplatin

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union 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 United States 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 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+