Trial Title:
FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer
NCT ID:
NCT06338657
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Albumin-Bound Paclitaxel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (FID-007)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (FID-007)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (FID-007)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Drug
Intervention name:
PEOX-based Polymer Encapsulated Paclitaxel FID-007
Description:
Given IV
Arm group label:
Treatment (FID-007)
Other name:
FID 007
Other name:
FID-007
Other name:
FID007
Other name:
Nanoencapsulated Paclitaxel FID-007
Other name:
Paclitaxel in Polyethyloxazoline Polymer
Intervention type:
Procedure
Intervention name:
Tumor Resection
Description:
Undergo surgical resection
Arm group label:
Treatment (FID-007)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To describe the phenotypical and functional changes of different T cell subsets within
the tumor microenvironment after treatment with FID-007.
SECONDARY OBJECTIVES:
I. To describe the adverse events associated with neoadjuvant FID-007 prior to surgery
for head and neck cancer.
II. To evaluate preliminary evidence of efficacy by describing the rate of major and
complete pathologic response.
III. To describe the rates of locoregional recurrence and rate of distant metastasis at 2
years after surgery.
EXPLORATORY OBJECTIVE:
I. Explore association between pathologic response and phenotypical and functional
changes in T cell subsets.
OUTLINE:
Patients receive FID-007 intravenously (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
computed tomography (CT) or magnetic resonance imaging (MRI) during screening and blood
sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Los Angeles General Medical Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sandy Tran, MS
Phone:
323-865-0451
Email:
Sandy.tran@med.usc.edu
Investigator:
Last name:
Jacob S. Thomas, MD
Email:
Principal Investigator
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sandy Tran, MS
Phone:
323-865-0451
Email:
Sandy.tran@med.usc.edu
Investigator:
Last name:
Jacob S. Thomas, MD
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06338657
