Head and Neck Cancer Clinical Trial
Official title:
Effect of PI3K Inhibition in HPV-Associated HNSCC
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may
help doctors learn more about changes that occur in DNA and identify biomarkers related to
cancer.
PURPOSE: This laboratory study is looking at the DNA in tumor tissue samples from patients
with human papilloma virus-associated cancer of the oropharynx.
OBJECTIVES:
- Analyze PIK3CA expression and mutation and p110α amplification and expression in tumor
tissue samples from patients with human papilloma virus positive (HPV+) and human
papilloma virus negative (HPV-) squamous cell carcinoma (SCC) of the oropharynx.
- Determine proliferation and survival after PI3K inhibition in HPV(+) and HPV(-)
oropharyngeal SCC cell lines and in HPV E6 and E7 expressing cells.
- Determine proliferation and survival after PI3K inhibition in short-term cultures of
tumor tissue samples from patients with HPV(+) and HPV(-) primary SCC of the
oropharynx.
OUTLINE: Previously collected tumor tissue samples are analyzed for HPV DNA by PCR
amplification and direct sequencing of PCR products; expression of E6 protein and relative
expression of PIK3CA by qRT-PCR; amplification of PIK3CA by Southern blotting; mutation of
PIK3CA; expression of p110α, phospho-AKT, total AKT, and FOXO1 by polyacrylamide gel
electrophoresis (PAGE) and immunoblotting; and the effect of PI3K inhibition on cell cycle
and apoptosis by flow cytometry. Pharmacological studies are performed on oropharyngeal
squamous cell carcinoma cell lines and short-term cultures and HPV E6 and E7 expressing
cells using LY 294002 in vitro to analyze response to PI3K inhibition. Results of response
to PI3K inhibition will be correlated with HPV status, PIK3CA expression, amplification, and
mutation, and p110α expression.
PROJECTED ACCRUAL: A total of 20 HPV(+) and 20 HPV(-) tumor tissue specimens from patients
will be accrued for this study.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |