Current partner codePEPTIDESDE
NCT04252612·Early Phase 1·INTERVENTIONAL

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

Status

Withdrawn

Phase

Early Phase 1

Enrollment

0

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Pramlintide

SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.

Timeline

From registration to results.

  1. First posted

    Feb 5, 2020

  2. Study start

    Jan 30, 2020

  3. Primary completion

    Jun 26, 2023

  4. Study completion

    Jun 26, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Jun 28, 2023

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Moffitt Cancer Center

Tampa, Florida, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.