Trial Outcomes & Findings for Pre-Treatment of Highly Suspicious Pigmented Skin Lesions With Interleukin-2 (NCT NCT03233828)
NCT ID: NCT03233828
Last Updated: 2024-07-24
Results Overview
Data will be analyzed in order to achieve a statistically significant differentiation between treatment and control outcomes in study measures including tumor infiltrating lymphocytes (TILs) and circulating immunomodulators.
TERMINATED
PHASE3
1 participants
1 year
2024-07-24
Participant Flow
Participant milestones
| Measure |
Intralesional IL-2 Injection
Two subcutaneous intralesional injections of Aldesleukin, prepared by the pharmacy such that the contents will be masked, will be administered by the care provider in a clinic seven days apart.
Aldesleukin: 500,000 IU in 0.1mL
|
Saline Injection
Two subcutaneous intralesional injections of Saline, prepared by the pharmacy such that the contents will be masked, will be administered by the care provider in a clinic seven days apart.
Saline: 0.1 mL of sterile saline solution (0.9% m/v)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intralesional IL-2 Injection
n=1 Participants
Two subcutaneous intralesional injections of Aldesleukin, prepared by the pharmacy such that the contents will be masked, will be administered by the care provider in a clinic seven days apart.
Aldesleukin: 500,000 IU in 0.1mL
|
Saline Injection
Two subcutaneous intralesional injections of Saline, prepared by the pharmacy such that the contents will be masked, will be administered by the care provider in a clinic seven days apart.
Saline: 0.1 mL of sterile saline solution (0.9% m/v)
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data were not collected for tumor infiltrating lymphocytes (TILs) and circulating immunomodulators because patient was lost to follow-up.
Data will be analyzed in order to achieve a statistically significant differentiation between treatment and control outcomes in study measures including tumor infiltrating lymphocytes (TILs) and circulating immunomodulators.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Assessments every 4 months for 2 years. Biannual assessments for years 3-5.Population: Assessment of new metastases data could not be collected as patient was lost to follow-up.
All patients will receive assessments every 4 months for 2 years and then biannual assessments for years 3-5 after the initial intervention to assess disease metastasis in treatment and control groups. Both number of new metastases (integer value) and thickness (mm) will be measured as a part of this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: RNA analysis of excised tissue up to 5 years.Population: Data were not collected for RNA analysis because patient was lost to follow-up.
RNA analysis of excised tissue will be compared to unaffected patient tissue obtained from the clear margins of the excisional biopsy to assess genetic changes resulting from the melanoma and treatment/placebo injections.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Proteomic analysis of serum samples up to 5 yearsPopulation: Data were not collected for proteomic analysis because patient was lost to follow-up.
Proteomic analysis will be conducted on blood samples to assess systemic immune response to both treatment and control groups. Serum collected from patient blood samples will be used for proteomic analysis to assess protein expression, including circulating immunomodulators (cytokines and chemokines) before, and after, treatment. This study may serve to help develop diagnostic protocols and methods of assessing response to treatments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Metabolomic analysis of urine samples up to 5 yearsPopulation: Data were not collected for metabolomic analysis because patient was lost to follow-up.
Metabolomic analysis will be conducted on urine samples to assess systemic immune response to both treatment and control groups. All tumor and tissue produce by products in waste that are excreted by the kidneys. Urine samples can be evaluated using techniques, such as Mass Spectrometric, to determine if biological compounds can be identified in association with the presence of a malignant process that would not be produced by normal tissue.This study may serve to help develop diagnostic protocols and methods of assessing response to treatments.
Outcome measures
Outcome data not reported
Adverse Events
Intralesional IL-2 Injection
Saline Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place