FID-007 for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Sandy Tran, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Southern California

Must not be taking: Taxane chemotherapies, Immunosuppressive therapy

Disqualifiers: Nasopharynx, Salivary gland, Skin, others

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

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapy, you must stop it at least 14 days before enrolling, except for a low dose of prednisone (10mg or less).

What data supports the effectiveness of the drug FID-007 for head and neck cancer?

Research shows that paclitaxel, a key component of FID-007, has demonstrated significant activity in treating head and neck cancer, with a 40% response rate in a clinical trial. Additionally, paclitaxel-loaded nanoparticles have shown higher antitumor efficacy and improved safety in a mouse model, suggesting potential benefits for head and neck cancer treatment. ^{1 2 3 4 5}

Is FID-007 generally safe for humans?

Research on paclitaxel-loaded nanoparticles, similar to FID-007, shows improved safety compared to traditional paclitaxel, with fewer side effects in animal models. Common side effects of paclitaxel include low white blood cell counts, nerve damage, and muscle pain, but the nanoparticle form may reduce these issues. ^{1 3 4 6 7}

What makes the drug FID-007 unique for head and neck cancer?

FID-007 is unique because it uses a polymer-based system to encapsulate paclitaxel, which allows for direct delivery to the tumor site, potentially increasing its effectiveness and reducing side effects compared to traditional paclitaxel treatments. ^{1 2 4 6 8}

What is the purpose of this trial?

This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery.

Research Team

Jacob Thomas, MD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for individuals with head and neck cancers, specifically squamous cell carcinoma. Participants should be candidates for surgery to remove their tumor. The study aims to understand how a new form of chemotherapy (FID-007) affects immune cells around the tumor before standard surgery.

Inclusion Criteria

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 X institutional upper limit of normal

Creatinine ≤ 1.5 X institutional upper limit of normal

My cancer is confirmed as head and neck squamous cell carcinoma.

Exclusion Criteria

I have been treated with taxane chemotherapies before.

My cancer originated in the nasopharynx, salivary gland, or skin.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to FID-007 or other agents used in study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive FID-007 intravenously over 30 minutes once a week for 3 weeks on days 1, 8, and 15 of a single 28 day cycle

4 weeks

3 visits (in-person)

Surgery

Participants undergo standard of care surgery approximately 3-6 weeks after the last dose of FID-007

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for 2 years

24 months

8 visits (in-person)

Treatment Details

Interventions

• PEOX-based Polymer Encapsulated Paclitaxel FID-007
• Tumor Resection

Trial Overview The trial tests FID-007, a PEOX-polymer encapsulated paclitaxel designed to target tumors more effectively while sparing normal cells. It's given before surgery, followed by imaging studies like CT and MRI, then surgical removal of the tumor and collection of tissue samples.

Participant Groups

Group I: Treatment (FID-007) Experimental Treatment 5 Interventions

Patients receive FID-007 IV over 30 minutes once a week for 3 weeks on days 1, 8, and 15 of a single 28 day cycle in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Patients undergo CT or MRI during screening and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The study developed a polymeric nanocarrier system for delivering paclitaxel (PTX) directly into tumors, which showed significantly higher antitumor efficacy and improved safety compared to free PTX in a mouse model of hypopharynx carcinoma.

PTX-loaded nanoparticles reduced tumor growth and markers of cell proliferation and angiogenesis, indicating that this targeted delivery method enhances the therapeutic effects of PTX while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-loaded polymeric nanoparticles based on α-tocopheryl succinate for the treatment of head and neck squamous cell carcinoma: in vivo murine model. Riestra-Ayora, J., Sánchez-Rodríguez, C., Palao-Suay, R., et al.[2022]

A regimen of concurrent chemoradiotherapy using a 120-hour infusion of paclitaxel resulted in a median survival of 56.5 months for patients with locally advanced squamous cell carcinoma of the head and neck, indicating effective long-term local control.

While the treatment was effective, it was associated with significant long-term toxicities, including hypothyroidism in 43% of patients, and complications such as xerostomia and esophageal strictures, though most toxicities were mild (grade 1 or 2).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes and toxicity of concurrent paclitaxel and radiotherapy for locally advanced head-and-neck cancer. Citrin, D., Mansueti, J., Likhacheva, A., et al.[2021]

The amphiphilic block copolymer PEO-PBO effectively forms nanoparticles for delivering the cancer drug paclitaxel, with a size of approximately 92.71 nm, which is suitable for targeting tumors due to the enhanced permeability and retention effect.

PEO-PBO nanoparticles demonstrated superior pharmacokinetics, biodistribution, and tumor inhibition compared to the commonly used PEG-PDLLA, along with better biocompatibility and stability, indicating its potential as a promising drug delivery system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of paclitaxel using nanoparticles composed of poly(ethylene oxide)-b-poly(butylene oxide) (PEO-PBO). Wang, L., Yao, J., Zhang, X., et al.[2018]

In a phase II trial involving 30 patients with recurrent head and neck cancer, high-dose paclitaxel (250 mg/m2) demonstrated a 40% response rate, indicating its potential effectiveness as a treatment option.

The main side effects observed were neutropenia, peripheral neuropathy, and arthralgias/myalgias, which are consistent with previous studies, suggesting that while paclitaxel is promising, careful monitoring for these toxicities is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol) for the treatment of head and neck cancer. Forastiere, AA.[2015]

In a Phase II trial involving 30 patients with recurrent head and neck cancer, high-dose paclitaxel (250 mg/m2) showed a 40% overall response rate, indicating its potential effectiveness in treating this type of cancer.

The treatment was associated with significant toxicities, including severe neutropenia in 91% of patients, highlighting the need for careful monitoring and management of side effects during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future trials of Taxol (paclitaxel) in head and neck cancer. Forastiere, AA.[2016]

The biodegradable polyanhydride polymer loaded with chemotherapy drugs demonstrated effective and sustained release of anticancer agents, with over 95% of methotrexate and fluorouracil released within 10 days, showing potential for targeted treatment of squamous cell carcinomas (SCCs).

In both in vitro and in vivo studies, the polymer-drug combination significantly inhibited tumor growth in human SCC models, achieving up to 96.6% cell death in culture and a substantial reduction in tumor size in nude mice, indicating its efficacy as a promising therapeutic option for head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polymer chemotherapy for head and neck cancer. Shikani, AH., Domb, AJ.[2013]

Paclitaxel shows promising activity against squamous cell carcinoma of the head and neck, with preliminary results from a phase II trial indicating two complete and seven partial responses among 19 patients.

While paclitaxel is effective, it is associated with significant toxicities, including grades 3 and 4 neutropenia and grades 1 and 2 neuropathy, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of paclitaxel (Taxol) in squamous cell carcinoma of the head and neck. Forastiere, AA.[2015]

In a study involving 65 patients with recurrent or metastatic head and neck cancer, the combination of paclitaxel, ifosfamide, and cisplatin showed a promising overall response rate of 55%, with 16% achieving complete responses and 39% partial responses.

The treatment regimen was well tolerated and resulted in a median survival of 8.9 months, suggesting significant antitumor activity and potential for further testing as an induction therapy in advanced cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in paclitaxel-containing chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck. Shin, DM., Glisson, BS., Khuri, FR., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Paclitaxel-loaded polymeric nanoparticles based on α-tocopheryl succinate for the treatment of head and neck squamous cell carcinoma: in vivo murine model. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes and toxicity of concurrent paclitaxel and radiotherapy for locally advanced head-and-neck cancer. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Delivery of paclitaxel using nanoparticles composed of poly(ethylene oxide)-b-poly(butylene oxide) (PEO-PBO). [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol) for the treatment of head and neck cancer. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Current and future trials of Taxol (paclitaxel) in head and neck cancer. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Polymer chemotherapy for head and neck cancer. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Use of paclitaxel (Taxol) in squamous cell carcinoma of the head and neck. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Recent advances in paclitaxel-containing chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck. [2015]