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Amylin Analog
Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
Phase < 1
Waitlist Available
Led By Nikhil Khushalani, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 44 days from on study date
Awards & highlights
No Placebo-Only Group
Summary
This trial will test pramlintide as a possible treatment for squamous cell carcinoma. Two weeks before surgery, patients will take pramlintide. Tissue from before and after treatment will be compared to see if there are any changes.
Eligible Conditions
- Skin Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 44 days from on study date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 44 days from on study date
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participant Compliance
Secondary study objectives
Number of Adverse Events
Side effects data
From 2022 Phase 4 trial • 22 Patients • NCT0184135918%
Hypoglycemia
14%
Nausea
5%
Ethanol abuse / intoxication
5%
Auditory hallucinations
5%
Cold feeling behind eyes.
5%
Trembling
5%
Diarrhea (with urgency and incontinence)
5%
Increase in baseline anxiety.
5%
Symptoms of a urinary tract infection (UTI) (CVA tenderness w/ dysuria)
5%
Nightmares
5%
Hyperglycemia
5%
Elevated liver enzymes
5%
Altered taste (during treatment with study drug)
5%
Cholecystitis (prior to treatment with study drug)
5%
Sinus infection (Visit 4, following treatment with study drug)
5%
Weight loss (during study drug treatment)
5%
Dehydration (r/t diarrhea)
5%
Diarrhea (assoc. with dehydration requiring hospitalization)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pramlintide (Symlin)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Pramlintide 120 mcg three times dailyExperimental Treatment1 Intervention
Participants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor.
Group II: Cohort 2: Pramlintide 60 mcg three times dailyExperimental Treatment1 Intervention
Participants will self inject Parmlintide 60 mcg three times daily for two weeks prior to surgical resection of tumor.
Group III: Cohort 1: Pramlintide 60 mcg twice dailyExperimental Treatment1 Intervention
Participants will self inject Pramlintide 60 mcg twice daily for two weeks prior to surgical resection of tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pramlintide
2022
Completed Phase 4
~110
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
567 Previous Clinical Trials
144,919 Total Patients Enrolled
Nikhil Khushalani, MDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
95 Total Patients Enrolled