Clinical Trials /

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

NCT04252612

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.

Related Conditions:
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
PramlintideSymlin, SymlinPenCohort 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

NameTypeDescriptionInterventions
Cohort 1: Pramlintide 60 mcg twice dailyExperimentalParticipants will self inject Pramlintide 60 mcg twice daily for two weeks prior to surgical resection of tumor.
  • Pramlintide
Cohort 2: Pramlintide 60 mcg three times dailyExperimentalParticipants will self inject Parmlintide 60 mcg three times daily for two weeks prior to surgical resection of tumor.
  • Pramlintide
Cohort 3: Pramlintide 120 mcg three times dailyExperimentalParticipants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor.
  • Pramlintide

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

January 30, 2020