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Cytokine
Aldesleukin for Melanoma (IL-2 Trial)
Phase 3
Waitlist Available
Led By Carman A Giacomantonio, MD, FRCSC
Research Sponsored by Carman Giacomantonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The participant population will include patients characterized by: nodular/polypoid features, bleeding/ulcerated lesions, excluding face and vulvo-genital lesions.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
IL-2 Trial Summary
This trial is studying whether a treatment can increase the infiltration of lymphocytes into melanoma lesions and whether this could decrease disease metastasis.
Eligible Conditions
- Melanoma
- Skin Cancer
IL-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIL-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Metastasis
Assessment of Number of Patients Needed to Obtain Significance
Secondary outcome measures
Assessment of RNA genetic profile
Assessment of Systemic Immune Response: Metabolomic Analysis
Assessment of Systemic Immune Response: Proteomic Analysis
Side effects data
From 2010 Phase 4 trial • 26 Patients • NCT0041476529%
Atrial fibrillation
14%
International normalised ratio increased
14%
Renal failure
14%
Sepsis
14%
Oliguria
14%
Mental status changes
14%
Chronic obstructive pulmonary disease
14%
Dyspnoea
14%
Respiratory failure
14%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
mRCC
Metastatic Melanoma
IL-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intralesional IL-2 InjectionExperimental Treatment1 Intervention
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.
Group II: Saline InjectionPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Find a Location
Who is running the clinical trial?
Nova Scotia Health AuthorityOTHER
254 Previous Clinical Trials
83,138 Total Patients Enrolled
2 Trials studying Melanoma
121 Patients Enrolled for Melanoma
Carman GiacomantonioLead Sponsor
1 Previous Clinical Trials
1 Trials studying Melanoma
Carman A Giacomantonio, MD, FRCSCPrincipal InvestigatorSurgical Oncologist / General Surgeon / Professor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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