TERMINATED

FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer

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Conditions

Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Window of Opportunity Study of Taxanes in Head and Neck Cancer

Quick Facts

Study Start:2024-04-01
Study Completion:2025-09-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06338657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have histopathologically / cytologically confirmed diagnosis of head and neck squamous cell carcinoma
  2. * Sites of primary tumor allowed include the oral cavity and oropharynx only. Patients with recurrent disease that is amenable to surgery are eligible
  3. * Patients may have any stage cancer amenable to surgical resection
  4. * 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
  5. * Patients with oropharynx cancer must have p16 negative disease
  6. * Age ≥ 18 years
  7. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  8. * Leukocytes ≥ 3,000/mcL
  9. * Absolute neutrophil count ≥ 1,500/mcL
  10. * Platelets ≥ 100,000/mcl
  11. * Hemoglobin ≥ 9 g/dl
  12. * Total bilirubin ≤ 1.5 X institutional upper limit of normal
  13. * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 X institutional upper limit of normal
  14. * Creatinine ≤ 1.5 X institutional upper limit of normal
  15. * 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.
  16. * 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:
  17. * Has not undergone a hysterectomy or bilateral oophorectomy; or
  18. * 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)
  19. * Ability to understand and the willingness to sign a written informed consent
  1. * Patients with primary sites of the nasopharynx, salivary gland, or skin
  2. * Patients that have been previously treated with taxane chemotherapies
  3. * Patients that have previously received radiation to the site of planned surgery
  4. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to FID-007 or other agents used in study
  5. * 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
  6. * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
  7. * Any diagnosis of immunodeficiency or patients receiving immunosuppressive therapy within 14 days of enrollment. Prednisone dose of ≤ 10mg is allowed

Contacts and Locations

Principal Investigator

Jacob Thomas, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Jacob Thomas, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-09-09

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-09-09

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Squamous Cell Carcinoma