DRUG
Pramlintide
SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
Status
Withdrawn
Phase
Early Phase 1
Enrollment
0
Locations
1
Results
Not posted
Publications
0
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.
Interventions
DRUG
SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
Timeline
First posted
Feb 5, 2020
Study start
Jan 30, 2020
Primary completion
Jun 26, 2023
Study completion
Jun 26, 2023
Results posted
Not reported
Registry updated
Jun 28, 2023
Outcomes
Participant Compliance
Time frame · at 14 days from on study date
Patients who complete at least 75% of the injections and have not missed 2 consecutive days of treatment will be considered compliant.
Number of Adverse Events
Time frame · at 44 days from on study date
Number of adverse events prior to surgery, during surgery and for 30 days after surgery that may be related to pramlintide injection.
Eligibility
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Moffitt Cancer Center
Tampa, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
University of Copenhagen · Healthy Adult Participants · Bone Physiology
Not applicable
Not yet recruiting
15
2026-07
Oregon Health and Science University · Type 1 Diabetes
Not applicable
Completed
33
2026-06
Boston University · Alzheimer Disease · Mild Cognitive Impairment
Early Phase 1
Active, not recruiting
57
2026-05
Esbjerg Hospital - University Hospital of Southern Denmark · Obesity · Appetite Regulation
Phase 2 / Phase 3
Withdrawn
0
2026-04
University Hospital, Gentofte, Copenhagen · Obesity & Overweight
Not applicable
Recruiting
18
2026-04
Danish Headache Center · Headache Disorders, Secondary · Brain Diseases
Not applicable
Not yet recruiting
21
2026-01
Danish Headache Center · Headache Disorders, Primary · Headache Disorders
Not applicable
Not yet recruiting
21
2026-01
McGill University Health Centre/Research Institute of the McGill University Health Centre · type1diabetes · Diabetes Mellitus, Type 1
Phase 2 / Phase 3
Unknown
30
2024-04
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.