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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether chemo-embolization can help people with head and neck cancer live longer without disease progression. Chemo-embolization delivers cisplatin directly to the tumor to determine if it is more effective than standard treatments like radiation or chemotherapy. It targets individuals with squamous cell carcinoma in the head and neck who cannot tolerate the typical drug cisplatin due to kidney, nerve, or hearing issues. Those planning to undergo regular cancer treatments but unable to tolerate standard cisplatin may find this trial suitable. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cisplatin chemo-embolization is generally well-tolerated by patients with head and neck cancer. One study found that this treatment led to positive results and improved survival rates, with mostly mild side effects. Another study discovered that cisplatin was quickly delivered directly to the tumor, limiting its effects on the rest of the body. This targeted method aims to reduce side effects while effectively fighting cancer. Overall, these findings suggest that cisplatin chemo-embolization is a promising treatment option with a reasonable level of safety for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for head and neck cancer, which often involve systemic chemotherapy or radiation, chemo-embolization with Cisplatin offers a targeted approach. This method involves directly infusing a Cisplatin suspension into the tumor's blood supply, which can potentially deliver a higher concentration of the drug right where it's needed while minimizing exposure to the rest of the body. Researchers are excited about this approach because it may enhance the drug's effectiveness against the tumor and reduce the side effects typically associated with chemotherapy. This targeted delivery could represent a significant advancement in treating head and neck cancer, providing a more efficient and potentially less harmful option for patients.

What evidence suggests that chemo-embolization might be an effective treatment for head and neck cancer?

Research has shown that high-dose intra-arterial cisplatin therapy, which participants in this trial will receive, can effectively treat head and neck cancer, achieving a 91% success rate in shrinking or eliminating tumors. This treatment delivers the chemotherapy drug cisplatin directly into the arteries supplying blood to the tumor. Studies have found that better results occur when the total dose of cisplatin exceeds 200 mg/m². This method shows promise, particularly for patients unable to undergo standard chemotherapy. However, some patients may experience side effects such as mouth sores and difficulty swallowing. Overall, this approach appears to be a promising option for challenging cases of head and neck cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Jesse Jones, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1930043324011919

Cisplatin intra-arterial chemotherapy for recurrent maxillary ... Intra-arterial infusion chemotherapy can be a promising strategy for recurrent head and neck cancer, provided it is performed under suitable conditions.

2. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/482423

High-Dose Intra-arterial Cisplatin Therapy Followed by ... Conclusions High-dose intra-arterial cisplatin therapy provides a high complete and partial response rate (91%). The combination of high-dose intra-arterial ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2019.37.15_suppl.6038

High-dose, short-duration, intra-arterial cisplatin therapy for ... This approach remarkably improves curative efficiency, but some adverse events, e.g., severe mucositis, dysphagia, dysgeusia, dry mouth, and ...

4. mdpi.com mdpi.com/2072-6694/17/9/1444

Comparison of Weekly and Triweekly Cisplatin Regimens ... Previous studies indicate that a cumulative cisplatin dose exceeding 200 mg/m2 is desirable and associated with improved therapeutic outcomes in patients with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39041364/

Effectiveness and feasibility of selective intra-arterial low ... The m-RADPLAT regimen yielded favorable survival rates and clinical outcomes in patients with impaired renal function.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/3943035/

Intra-arterial continuous infusion of cis- ... Treatment consisted of cisplatin 10 mg infused intra-arterially in a 12-hour period, twice a day for 5 to 10 days via an external infusion pump. After a rest ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408240/

PMC Search Update ... intra-arterial cisplatin infusion, head and neck squamous cell carcinoma ... head and neck cancer: results of a randomized phase 3 trial.

8. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.938305/full

Efficacy and safety of transarterial chemoembolization with ... Conclusion: CSM-TACE illustrates favorable treatment response and survival benefits as well as a tolerable safety profile in HNC patients.

9. researchgate.net researchgate.net/publication/10772341_Cisplatin_tumor_concentrations_after_intra-arterial_cisplatin_infusion_or_embolization_in_patients_with_oral_cancer

Cisplatin tumor concentrations after intra-arterial ... Cisplatin was rapidly administered through the intra-arterial catheter and STS (9 g/m(2)) was infused intravenously to reduce the systemic ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT00006106

ONYX-015 With Cisplatin and Fluorouracil in Treating ... PURPOSE: Phase I trial to study the effectiveness of ONYX-015 combined with cisplatin and fluorouracil in treating patients who have advanced head and neck ...