Metastatic CancerNCT03176485
Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors
A study testing Solar Simulator in people with Metastatic Cancer and Melanoma, run by University of Arizona at 1 site in United States.
Trial summary
This is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the tyrosine kinase pathway in the presence or absence of solar simulated light exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Melanoma, Colon Cancer
- What is being tested?
- Solar Simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2014to 1 Nov 2018
- Phase
- Interventional
- 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
- Subjects who have not yet initiated but plan to undergo dosing with a Tyrosine Kinase inhibitor (TKI) or Raf inhibitor, either alone or with a MEK inhibitor, for treatment of metastatic melanoma, colon cancer, hepatic cell carcinoma, or thyroid cancer.
- Individuals with normal skin and Fitzpatrick skin type II, III or IV.
- Individuals who are willing to limit sun exposure to the body during the study period, and who agree to wear protective clothing and SPF 50 broad spectrum sunscreen or sunblock on exposed skin when they are outdoors.
- Individuals who have the ability to understand and willingness to sign an informed consent before initiation of study procedures, after the nature of the study is explained to them and they have asked any questions.
- Individuals with a Karnofsky Performance Status of at least 80%.
Who cannot join
- Individuals with any inflammation or irritation of the skin at the test area (buttocks), or any skin conditions felt by the study physician to contraindicate enrollment.
- Individuals with a history of any skin cancer, melanocytic lesions, actinic keratoses or actinic damage in the test area are ineligible. History of such conditions at a body site other than the test area is not exclusionary if in the opinion of the study physician it will not pose a risk to the subject.
- Individuals who are immunosuppressed by virtue of medication or disease, as determined by the examining study physician. This includes AIDS patients and subjects taking oral steroids.
- Individuals with active infection, psychiatric illness, or other situations that in the opinion of the study physician limit compliance or interfere with the study regimen.
- Individuals with a history of photosensitive diseases including, but not limited to, Lupus Erythematosus, pseudoporphyria, or other diseases that in the opinion of the study physician would pose a risk to the subject or interfere with the study.
- Individuals who have used photosensitizing drugs within the last 30 days prior to study enrollment, or who will be using a photosensitizing drug during the time of the study.
Show all 14Show fewer
- Individuals who have used any topical medication other than emollients on the test area within 30 days prior to study enrollment.
- Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or Imiquimod (Aldara®) anywhere on the body within 30 days prior to enrollment.
- Individuals must not take mega-doses of vitamins. Mega-doses are defined as more than 5 capsules of standard multivitamins daily or more than the Tolerable Upper Intake Levels of Vitamins, as defined by the Institute of Medicine, National Academy of Sciences. Such vitamin therapy must be discontinued at least 30 days prior to study entry.
- Individuals with a history of natural or artificial sun exposure to the buttocks within 30 days of study participation.
- Individuals with Fitzpatrick skin type I
- Individuals with Fitzpatrick skin type V or VI
- Individuals enrolled in or who plan to enroll in a clinical intervention trial. There must be a 30-day period between completing a previous study and enrolling in this study. The Principal Investigator will have the option to consider an exception for patients on drugs of interest for the purpose of this study.
- Individuals with a known allergy to lidocaine.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Pilot Study to Evaluate the Signaling Pathway Modulation Demonstrated by Raf, MEK, and Kinase Inhibitors In Human Skin With or Without Solar Simulated Light
This is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the tyrosine kinase pathway in the presence or absence of solar simulated light exposure.
A maximum of 45 subjects will be accrued into the overall study we anticipate approximately 25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK inhibitor arms of the study.
Read the detailed description
The study will evaluate the modulatory effect of systemic Raf inhibition in the MEK/ERK and PI3 /Akt/mTOR pathways in patients undergoing targeted therapy for metastatic disease.
Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology.
The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light
- Conditions
- Metastatic Cancer, Melanoma, Colon Cancer, Differentiated Thyroid Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma
- Being tested
- Solar Simulator
- Keywords
- metastatic, melanoma, cancer, colon, thyroid, Differentiated, Hepatocellular Carcinoma, HCC, RCC, Renal Cell Carcinoma
- Medical subject headings
- Neoplasm Metastasis, Melanoma, Colonic Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solar SimulatorOther
Also called Multiport UV Solar Simulator Model 60
A Multiport UV Solar Simulator Model 600 (Solar Light Co., Inc., Philadelphia, PA) will be used to administer Solar Simulated Light (SSL) exposures to formerly unexposed buttock skin.The device is equipped with six 8mm liquid light guides (LLG), allowing for 6 simultaneously conducted exposures.A large 3x2 endplate places the LLGs several centimeters apart and is specifically designed for Sun Protection Factor (SPF) and photo patch testing. The dose of emission from each LLG can be precisely regulated and the spectrum of emission can be limited to UVA (320-390 nm) or UVB+UVA (290-390 nm). The operator can select between UVA only and a combined Ultraviolet-A (UVA)/ Ultraviolet-B (UVB) spectrum by placement of an optical filter. The spectral output (indicated below) follows the distribution of sunlight from 290 to 390 nm.
| Study group | Role | What they receive |
|---|---|---|
| ArmA: With Solar Simulated Light Exposure | Experimental | Not described Receives: Other: Solar Simulator |
| ArmB: With Solar Simulated Light Exposure (Vemurafenib/Dabraf) | Experimental | Subjects in this study arm undergo the same procedures as Arm A, with the addition of a blood test for the presence of porphyrins Receives: Other: Solar Simulator |
| ArmC: Without Solar Simulated Light Exposure | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease
The primary endpoint of the study is to evaluate the modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease. Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology. The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light.
Measured: 2 months
Secondary outcomes (5)
Downstream modulation of direct Ras and MEK inhibition in human keratinocytes and melanocytes following acute solar simulated light exposure in the presence of metastatic disease treatment with Tyrosine kinase and MEK inhibitors.
The modulatory effect will be evaluated using IHC and RPPA technology.
Measured: 2 months
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in eligible melanocytic nevi.
Measured: 2 months
Correlate the type and severity of cutaneous squamous cell carcinoma development in patients treated with BRaf inhibitors and the modulatory profile identified in the proposed primary endpoint.
Measured: 2 months
Safety of performing solar simulated light studies in patients undergoing Ras inhibition for metastatic disease.
Measured: 2 months
Modulatory effect of Ras inhibition in Epidermal Growth Factor Receptor (EGFR) and Activating Protein-1 (AP1) signaling pathways (IHC and RPPA).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start17 Oct 2014
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clara Curiel-Lewandroski, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176485
- Sponsor's protocol ID
- 1409505107
- Status last verified
- Jan 2019
- First submitted
- 1 Jun 2017
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Signaling Pathway Modulation Demonstrated by Raf, MEK, and Kinase Inhibitors In Human Skin With or Without Solar Simulated Light
- ClinicalTrials.gov ID
- NCT03176485
- Acronym / sponsor ID
- 1409505107
- Conditions
- Metastatic Cancer, Melanoma, Colon Cancer, Differentiated Thyroid Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma
- Keywords
- metastatic, melanoma, cancer, colon, thyroid, Differentiated, Hepatocellular Carcinoma, HCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 17 Oct 2014 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 5 Jun 2017 (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 is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the tyrosine kinase pathway in the presence or absence of solar simulated light exposure.
A maximum of 45 subjects will be accrued into the overall study we anticipate approximately 25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK inhibitor arms of the study.
Detailed description
The study will evaluate the modulatory effect of systemic Raf inhibition in the MEK/ERK and PI3 /Akt/mTOR pathways in patients undergoing targeted therapy for metastatic disease.
Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology.
The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ArmA: With Solar Simulated Light Exposure | Experimental | Other: Solar Simulator |
| ArmB: With Solar Simulated Light Exposure (Vemurafenib/Dabraf) | Experimental | Other: Solar SimulatorSubjects in this study arm undergo the same procedures as Arm A, with the addition of a blood test for the presence of porphyrins |
| ArmC: Without Solar Simulated Light Exposure | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who have not yet initiated but plan to undergo dosing with a Tyrosine Kinase inhibitor (TKI) or Raf inhibitor, either alone or with a MEK inhibitor, for treatment of metastatic melanoma, colon cancer, hepatic cell carcinoma, or thyroid cancer.
- Individuals with normal skin and Fitzpatrick skin type II, III or IV.
- Individuals who are willing to limit sun exposure to the body during the study period, and who agree to wear protective clothing and SPF 50 broad spectrum sunscreen or sunblock on exposed skin when they are outdoors.
- Individuals who have the ability to understand and willingness to sign an informed consent before initiation of study procedures, after the nature of the study is explained to them and they have asked any questions.
- Individuals with a Karnofsky Performance Status of at least 80%.
Key exclusion criteria (14 listed)
- Individuals with any inflammation or irritation of the skin at the test area (buttocks), or any skin conditions felt by the study physician to contraindicate enrollment.
- Individuals with a history of any skin cancer, melanocytic lesions, actinic keratoses or actinic damage in the test area are ineligible. History of such conditions at a body site other than the test area is not exclusionary if in the opinion of the study physician it will not pose a risk to the subject.
- Individuals who are immunosuppressed by virtue of medication or disease, as determined by the examining study physician. This includes AIDS patients and subjects taking oral steroids.
- Individuals with active infection, psychiatric illness, or other situations that in the opinion of the study physician limit compliance or interfere with the study regimen.
- Individuals with a history of photosensitive diseases including, but not limited to, Lupus Erythematosus, pseudoporphyria, or other diseases that in the opinion of the study physician would pose a risk to the subject or interfere with the study.
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 |
|---|---|---|
| Solar SimulatorAlso: Multiport UV Solar Simulator Model 60A Multiport UV Solar Simulator Model 600 (Solar Light Co., Inc., Philadelphia, PA) will be used to administer Solar Simulated Light (SSL) exposures to formerly unexposed buttock skin.The device is equipped with six 8mm liquid light guides (LLG), allowing for 6 simultaneously conducted exposures.A large 3x2 endplate places the LLGs several centimeters apart and is specifically designed for Sun Protection Factor (SPF) and photo patch testing. The dose of emission from each LLG can be precisely regulated and the spectrum of emission can be limited to UVA (320-390 nm) or UVB+UVA (290-390 nm). The operator can select between UVA only and a combined Ultraviolet-A (UVA)/ Ultraviolet-B (UVB) spectrum by placement of an optical filter. The spectral output (indicated below) follows the distribution of sunlight from 290 to 390 nm. | Other | ArmA: With Solar Simulated Light Exposure, ArmB: With Solar Simulated Light Exposure (Vemurafenib/Dabraf) |
Primary outcome
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease
Time frame: 2 months
The primary endpoint of the study is to evaluate the modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease. Changes in relevant proteins will be evaluated using a combined protein expression methodology that in includes immunohistochemistry (IHC) and reverse phase protein microarray (RPPA) technology. The primary endpoint of this study will be assessed in normal skin and skin acutely exposed to solar simulated light.
5 secondary outcomes
Downstream modulation of direct Ras and MEK inhibition in human keratinocytes and melanocytes following acute solar simulated light exposure in the presence of metastatic disease treatment with Tyrosine kinase and MEK inhibitors.
Time frame: 2 months
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in eligible melanocytic nevi.
Time frame: 2 months
Correlate the type and severity of cutaneous squamous cell carcinoma development in patients treated with BRaf inhibitors and the modulatory profile identified in the proposed primary endpoint.
Time frame: 2 months
Safety of performing solar simulated light studies in patients undergoing Ras inhibition for metastatic disease.
Time frame: 2 months
Modulatory effect of Ras inhibition in Epidermal Growth Factor Receptor (EGFR) and Activating Protein-1 (AP1) signaling pathways (IHC and RPPA).
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- 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.
Clara Curiel-Lewandroski principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solar Simulator in people with Metastatic Cancer and Melanoma, run by University of Arizona 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 4 Jan 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modulatory effect of systemic Raf inhibition in the MEK/Erk and PI3 /AKT/mTOR pathways in patients undergoing targeted therapy for metastatic disease (time frame: 2 months). 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 4 Jan 2019.