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Cytokine
High-dose IL-2 + Radiation Therapy for Melanoma (SBRT/IL-2 Trial)
Phase 2
Waitlist Available
Led By Marka Crittenden, MD, PhD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy
ECOG performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks following cycle 2 (week 21).
Awards & highlights
SBRT/IL-2 Trial Summary
This trial is testing whether adding radiation therapy to high-dose IL-2 improves response rates in people with metastatic melanoma.
Who is the study for?
This trial is for adults with metastatic melanoma who have up to three tumors suitable for targeted radiation in specific body areas. Women must test negative for pregnancy and agree to prevent conception. Participants need normal heart, lung function tests, and acceptable blood counts. Those with brain metastases not eligible for radiosurgery or previous radiation in the target area cannot join.Check my eligibility
What is being tested?
The study compares two treatments: one group receives high-dose IL-2 alone, while the other gets both high-dose IL-2 and targeted radiation therapy (SBRT). The goal is to see which treatment better controls metastatic melanoma.See study design
What are the potential side effects?
High-dose IL-2 can cause flu-like symptoms, low blood pressure, fatigue, nausea, diarrhea, skin rash and increased risk of infections. Radiation may lead to localized skin reactions, fatigue and potential damage to nearby organs depending on the site treated.
SBRT/IL-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have confirmed I am not pregnant and will prevent pregnancy during the trial.
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I am fully active or can carry out light work.
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I am 18 years old or older.
SBRT/IL-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks following cycle 2 (week 21).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks following cycle 2 (week 21).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
Secondary outcome measures
Response Rate in Crossover Patients
SBRT/IL-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: SBRT + IL-2Experimental Treatment1 Intervention
Patients will receive two doses of radiation before receiving high-dose IL-2.
Group II: Arm A: IL-2 MonotherapyActive Control1 Intervention
Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.
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Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,491 Total Patients Enrolled
10 Trials studying Melanoma
260 Patients Enrolled for Melanoma
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
4,752 Total Patients Enrolled
4 Trials studying Melanoma
1,285 Patients Enrolled for Melanoma
Marka Crittenden, MD, PhDPrincipal InvestigatorProvidence Health & Services
2 Previous Clinical Trials
14 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to take steroids regularly for my health condition.I have confirmed I am not pregnant and will prevent pregnancy during the trial.Your white blood cell count is less than 3.0 x 10^9 per liter.My lung function tests are below 70% of what's expected due to lung disease.My cancer has 1-3 treatable tumors in specific areas, none larger than 7 cm.Your liver enzymes (AST/ALT) are more than three times the normal range.I currently have an infection in my body, lungs, or around my heart.I have not had radiation on the areas to be treated in this study.I have brain metastases and cannot undergo radiosurgery.Your creatinine level is higher than 1.9 g/dL.You need to have had a biopsy or cytology test confirming that you have melanoma.I am fully active or can carry out light work.Your hemoglobin level is less than 9.0 grams per deciliter.I am 18 years old or older.You have signs of reduced blood flow to your heart during a stress test or EKG.Your total bilirubin level is higher than 1.9 g/dL.My cancer cannot be treated with targeted radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: IL-2 Monotherapy
- Group 2: Arm B: SBRT + IL-2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any FDA-approved treatments which use both Radiation therapy and high-dose IL-2?
"There is some clinical data supporting the safety of this radiation therapy and high-dose IL-2 combination, but not yet efficacy. So, it received a score of 2."
Answered by AI
Are we currently looking for new participants in this trial?
"As of now, this trial is not enrolling patients. The listing for this clinical study was first posted on July 1st, 2011 and updated as recently as October 26th, 2022. If you are hoping to participate in other trials, there are 795 studies for melanoma and 25 for Radiation therapy and high-dose IL-2 that are looking for participants."
Answered by AI
Have other similar trials been conducted previously?
"Radiation therapy in conjunction with high-dose IL-2 has been an active area of research since 2006. The first study was sponsored by Key Biologics, LLC and took place that same year. It involved 1230 participants. After this initial Phase 2 trial, the drug approval process began. There are now 25 live studies involving Radiation therapy and high-dose IL-2 across 45 cities in 10 countries."
Answered by AI
Are there any other scientific papers which explore the use of Radiation therapy in combination with high-dose IL-2?
"There are currently 25 active clinical trials researching the combination of radiation therapy and high-dose IL-2, with none in Phase 3. While several of the trials are running out of steam in Meldola, FC, there are 71 other locations across the globe where research is still ongoing."
Answered by AI
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