Clinical Trial 19708

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT04252612

Phase: N/A
Principal Investigator: Khushalani, Nikhil

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Overview

Study Title

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

Summary

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.

Objective

The purpose of the study is to: 1) Determine the feasibility of patients willing to self-inject pramlintide up to three times daily for two weeks prior to surgical resection of their tumor. 2) Determine if two weeks of SQ pramlintide injections prior to surgery are safe 3) Determine if tissues collected pre- and post- treatment demonstrate detectable biological changes in response to pramlintide treatment

Treatments

Therapies

Surgery; Therapy (NOS)

Medications

Pramlintide ()

Inclusion Criteria

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) > 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

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

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