Using FID-007 to treat head and neck cancer before surgery
A Window of Opportunity Study of Taxanes in Head and Neck Cancer
This study is testing a new treatment called FID-007 to see if it can help improve the immune response in patients with head and neck cancer before they have surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | radiation, Prednisone, chemotherapy |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06338657 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the effects of FID-007, a PEOX-based polymer encapsulated form of paclitaxel, on immune cells in patients with head and neck squamous cell carcinoma. Patients will receive FID-007 intravenously for three weeks before undergoing standard surgical treatment. The study aims to assess changes in T cell subsets within the tumor microenvironment, evaluate adverse events, and gather preliminary efficacy data regarding tumor response. Follow-up will occur every three months for two years to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed head and neck squamous cell carcinoma who are eligible for surgical resection.
Not a fit: Patients with fine needle aspiration samples or those with p16 positive or non-resectable tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with head and neck cancer.
How similar studies have performed: Other studies have shown promise with similar approaches using encapsulated chemotherapy agents, but this specific formulation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients must have histopathologically / cytologically confirmed diagnosis of head and neck squamous cell carcinoma
* Sites of primary tumor allowed include the oral cavity and oropharynx only. Patients with recurrent disease that is amenable to surgery are eligible
* Patients may have any stage cancer amenable to surgical resection
* Patients must be able to provide an archival tissue specimen. Excisional biopsy or core needle biopsy specimens are allowed. Fine needle aspiration samples are not acceptable
* Patients with oropharynx cancer must have p16 negative disease
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Leukocytes ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcl
* Hemoglobin ≥ 9 g/dl
* Total bilirubin ≤ 1.5 X institutional upper limit of normal
* 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
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* Patients with primary sites of the nasopharynx, salivary gland, or skin
* Patients that have been previously treated with taxane chemotherapies
* Patients that have previously received radiation to the site of planned surgery
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to FID-007 or other agents used in study
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
* Any diagnosis of immunodeficiency or patients receiving immunosuppressive therapy within 14 days of enrollment. Prednisone dose of ≤ 10mg is allowed
Where this trial is running
Los Angeles, California and 1 other locations
- Los Angeles General Medical Center — Los Angeles, California, United States (Recruiting)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jacob Thomas, MD — University of Southern California
- Study coordinator: Sandy Tran, MS
- Email: Sandy.Tran@med.usc.edu
- Phone: 323-865-0451
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.