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Cytokine
Interleukin-2 for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by Cancer Biotherapy Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiovascular: No prior myocardial infarction within 6 months, No LVEF less than 35%, No primary cardiac arrhythmias beyond occasional PVCs, No angina, No uncontrolled congestive heart failure, No cerebrovascular accident
Pulmonary: No dyspnea at rest or requirement for supplemental oxygen, Oxygen saturation greater than 90% for patients with symptomatic lung disease
Must not have
Endocrine therapy: At least 3 weeks since prior corticosteroids, No concurrent corticosteroids
Other: At least 3 weeks since prior immunosuppressive medications, No concurrent immunosuppressive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well interleukin-2 works in treating patients with kidney cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults who've had surgery to remove stage III or IV kidney cancer and are at high risk of the cancer coming back. They should not have brain metastases, recent heart attacks, certain heart/lung conditions, psychiatric disorders, or be pregnant/nursing. Participants must meet specific health criteria and agree to avoid pregnancy.
What is being tested?
The study is testing Interleukin-2's effectiveness in preventing the return of kidney cancer after surgical removal. It's a Phase II trial focusing on how well this treatment stimulates white blood cells to destroy any remaining cancer cells.
What are the potential side effects?
Interleukin-2 can cause flu-like symptoms such as fever and chills, fatigue, nausea, vomiting, diarrhea, skin rash and itching. It may also affect normal blood counts and organ function which will be closely monitored during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is healthy with no recent major issues.
Select...
I don't need extra oxygen and can breathe normally.
Select...
My kidney cancer was removed surgically and is at high risk of coming back.
Select...
My cancer has spread beyond a specific area in my kidney.
Select...
My liver function tests are within normal limits.
Select...
My cancer has spread to the renal vein or vena cava.
Select...
All my cancerous lymph nodes have been surgically removed.
Select...
My cancer has not spread to my brain.
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My creatinine level is 1.9 mg/dL or lower.
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My cancer has spread to my adrenal gland or nearby tissues but not beyond a specific boundary.
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My cancer has spread to the large vein above my stomach.
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All of my cancer that spread has been surgically removed.
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I am able to get out of my bed or chair and move around.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken corticosteroids in the last 3 weeks and am not currently taking any.
Select...
I haven't taken any immunosuppressive medications in the last 3 weeks.
Select...
I am not currently taking cyclosporine or methotrexate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Who is running the clinical trial?
Cancer Biotherapy Research GroupLead Sponsor
12 Previous Clinical Trials
100 Total Patients Enrolled
Datchen F. Tai, MDStudy ChairCancer Biotherapy Research Group
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart is healthy with no recent major issues.My age does not affect my eligibility.I don't need extra oxygen and can breathe normally.My liver function tests are within normal limits.I haven't taken corticosteroids in the last 3 weeks and am not currently taking any.My kidney cancer was removed surgically and is at high risk of coming back.My cancer has spread beyond a specific area in my kidney.It has been more than 2 weeks since my last surgery.I haven't taken any immunosuppressive medications in the last 3 weeks.My cancer has spread to the renal vein or vena cava.All my cancerous lymph nodes have been surgically removed.My cancer has not spread to my brain.My creatinine level is 1.9 mg/dL or lower.My cancer has spread to my adrenal gland or nearby tissues but not beyond a specific boundary.I am not currently taking cyclosporine or methotrexate.My cancer has spread to the large vein above my stomach.All of my cancer that spread has been surgically removed.I am able to get out of my bed or chair and move around.
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.
Research Study Groups:
This trial has the following groups: