Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study

This study will treat resectable cutaneous squamous cell carcinoma patients with pramlintide for two weeks prior to surgical resection of their tumor. Pre-treatment and surgical resection specimens will then be analyzed for biological alterations.

Study Overview

• Status: Withdrawn
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Pramlintide

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically proven cutaneous squamous cell carcinoma. Mixed histologies (basaloid, spindle, sarcomatoid, etc.) are allowed if the pathology review favors squamous cell carcinoma as the majority component. Cancers of unknown primary sites are allowed if the clinical history and the site are highly suggestive of a skin cancer primary
• Tumor site must be amenable for surgical resection and accessible for pre-treatment biopsy
• Tumor site must be measurable by caliper measurements or by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 imaging - lesions must be ≥1 cm
• Eastern Cooperative Oncology Group (ECOG) ≤2 and be medically able to undergo surgical resection
• Laboratory Requirements: Hemoglobin ≥ 8 g/dl, Platelet count ≥ 50,000/dl, Serum Creatinine ≤ 1.5 mg/dL OR Glomular Filtration Rate (GFR) ≥ 40, Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2.5x ULN; Total Bilirubin < 1.5x ULN (for patients with documented history of Gilbert's syndrome, total bilirubin level should be < 3.0 X ULN)
• Ability to understand and willingness to sign a written informed consent document
• Patients with child bearing potential must be willing to use barrier protection to prevent pregnancy while on study therapy and up to 30 days after the last dose of pramlintide
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Patients must be willing to comply with the protocol for the duration of the treatment including daily sub-cutaneous (SQ) injections, biopsies, scheduled visits and examinations, radiologic studies, and surgical resection

Exclusion Criteria:

• Type I diabetes: Type II diabetics (DM2) on insulin are allowed, however, for those DM2 patients that are on short acting insulin, the insulin dose should be reduced 50% and need to have regular glucose monitoring (see section 6.2.1). Type II diabetics not on insulin will not be eligible.
• Patients with known gastroparesis
• Patients with known allergic reactions to pramlintide or its ingredients
• Pregnant women and/or nursing patients will be excluded from this study because of unknown risks to fetus or nursing infants
• Any serious or uncontrolled medical disorder that could interfere with the current study as deemed by the investigating physician
• Participation in any other clinical study using an investigational agent within 21 days of starting treatment on this protocol
• No prior chemotherapy, radiation, or other tumor directed therapy within 21 days prior of starting treatment on this protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Pramlintide 60 mcg twice daily; Participants will self inject Pramlintide 60 mcg twice daily for two weeks prior to surgical resection of tumor.	Drug: Pramlintide; SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.; Other Names: Symlin; SymlinPen
Experimental: Cohort 2: Pramlintide 60 mcg three times daily; Participants will self inject Parmlintide 60 mcg three times daily for two weeks prior to surgical resection of tumor.	Drug: Pramlintide; SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.; Other Names: Symlin; SymlinPen
Experimental: Cohort 3: Pramlintide 120 mcg three times daily; Participants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor.	Drug: Pramlintide; SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.; Other Names: Symlin; SymlinPen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Compliance	Patients who complete at least 75% of the injections and have not missed 2 consecutive days of treatment will be considered compliant.	at 14 days from on study date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Number of adverse events prior to surgery, during surgery and for 30 days after surgery that may be related to pramlintide injection.	at 44 days from on study date

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Nikhil Khushalani, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Hypoglycemic Agents; Physiological Effects of Drugs; Pramlintide
• Other Study ID Numbers: MCC-19708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes