Cutaneous Squamous Cell CarcinomaEarly Phase 1NCT04252612
Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
A Early Phase 1 study testing Pramlintide in people with Cutaneous Squamous Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Pramlintide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 26 Jun 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Pramlintide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramlintideDrug
Also called Symlin, SymlinPen
SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pramlintide |
| 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. Receives: Drug: Pramlintide |
| 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. Receives: Drug: Pramlintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Compliance
Patients who complete at least 75% of the injections and have not missed 2 consecutive days of treatment will be considered compliant.
Measured: at 14 days from on study date
Secondary outcomes (1)
Number of Adverse Events
Number of adverse events prior to surgery, during surgery and for 30 days after surgery that may be related to pramlintide injection.
Measured: at 44 days from on study date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Jan 2020
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikhil Khushalani, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252612
- Sponsor's protocol ID
- MCC-19708
- Status last verified
- Jun 2023
- First submitted
- 30 Jan 2020
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT04252612
- Acronym / sponsor ID
- MCC-19708
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Pramlintide 60 mcg twice daily | Experimental | Drug: PramlintideParticipants 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 | Drug: PramlintideParticipants 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 | Drug: PramlintideParticipants will self inject Parmlintide 120 mcg three times daily for two weeks prior to surgical resection of tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PramlintideAlso: Symlin, SymlinPenSymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide. | Drug | Cohort 1: Pramlintide 60 mcg twice daily, Cohort 2: Pramlintide 60 mcg three times daily, Cohort 3: Pramlintide 120 mcg three times daily |
Primary outcome
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.
1 secondary outcome
Number of Adverse Events
Time frame: at 44 days from on study date
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil Khushalani, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pramlintide in people with Cutaneous Squamous Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Compliance (time frame: at 14 days from on study date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.