Biological Outcomes of Pramlintide in Resectable Cutaneou... | NCT04252612

NCT04252612

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Pramlintide 60 mcg twice daily	Experimental	Participants will self inject Pramlintide 60 mcg twice daily for two weeks prior to surgical resection of tumor.	Drug: Pramlintide
Cohort 2: Pramlintide 60 mcg three times daily	Experimental	Participants will self inject Parmlintide 60 mcg three times daily for two weeks prior to surgical resection of tumor.	Drug: Pramlintide
Cohort 3: Pramlintide 120 mcg three times daily	Experimental	Participants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor.	Drug: Pramlintide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pramlintide	Drug	SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.	Cohort 1: Pramlintide 60 mcg twice daily

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

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

Eligibility Module

Eligibility 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) < 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