Description:
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.
Title
- Brief Title: Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
- Official Title: Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
Clinical Trial IDs
- ORG STUDY ID:
MCC-19708
- NCT ID:
NCT04252612
Conditions
- Cutaneous Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Pramlintide | Symlin, SymlinPen | Cohort 1: Pramlintide 60 mcg twice daily |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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. | |
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. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Participant Compliance |
Time Frame: | at 14 days from on study date |
Safety Issue: | |
Description: | Patients who complete at least 75% of the injections and have not missed 2 consecutive days of treatment will be considered compliant. |
Secondary Outcome Measures
Measure: | Number of Adverse Events |
Time Frame: | at 44 days from on study date |
Safety Issue: | |
Description: | Number of adverse events prior to surgery, during surgery and for 30 days after surgery that may be related to pramlintide injection. |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Last Updated
April 8, 2021