The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants will be administered 1 mg/mL Cisplatin via intralesional injection in combination with Epinephrine injection therapy. Total treatment volume will determined by the volume of the tumor to be injected.
Participants will be administered a 1:50,000 dilution of epinephrine via intralesional injection in combination with cisplatin therapy. The total treatment volume will determined by the volume of the tumor to be injected.
At the time of the first intralesional chemotherapy (IC) dose, participants will have a biopsy of tumor tissue taken for standard of care (SOC) clinical activities. A portion of this sample will, if available, be banked for transcriptomic analysis.
University of Miami
Miami, Florida, United States
RECRUITINGOverall Pathologic Response Rate (OPRR)
Overall Pathologic Response Rate (OPRR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment. ORRR will be assessed by pathology as percentage viable tumor on histopathology at time of surgical resection.
Time frame: About six (6) weeks
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion.
Time frame: About 18 weeks
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion.
Time frame: About 18 weeks
Overall Radiographic Response Rate (ORRR)
Overall Radiographic Response Rate (ORRR) is defined as the number of participants with a complete responses (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment by radiography (percent regression on computed tomography (CT) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, per physician discretion.
Time frame: About five (5) weeks
Overall Endoscopic Response Rate (OERR)
Overall Endoscopic Response Rate (OERR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment by endoscopy (percent regression determined by blinded raters of pre- and post-IC endoscopy).
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Participants with early disease will go on to have endoscopic surgical resection of their cancer while participants with advanced disease will receive a total laryngectomy, after completion of intralesional chemotherapy (IC) therapy. Resected tissue collected at the time of the surgical procedure (either cordectomy or total laryngectomy) will also be banked for correlative studies.
Time frame: About five (5) weeks