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Cytokine
Interleukin-2 + Vinblastine + GM-CSF for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by Hope Cancer Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age over 18
Cardiovascular: Adequate cardiac function, No unstable angina, No significant coronary artery disease, No heart failure with New York Heart Association classification III or IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test the effectiveness of combining low-dose interleukin-2, vinblastine, and GM-CSF in treating patients with metastatic kidney cancer.
Who is the study for?
This trial is for adults over 18 with inoperable, metastatic kidney cancer. They should have measurable disease, no brain metastases, decent performance status (SWOG 0-2), and a life expectancy of at least 3 months. Participants need normal blood counts, liver enzymes not too high, good renal function (creatinine <1.5 mg/dL), stable heart condition without severe coronary issues or advanced heart failure, and no serious lung disease. Prior treatments are limited to one biologic therapy, chemotherapy or hormonal therapy each.Check my eligibility
What is being tested?
The study tests the combination of low-dose interleukin-2 with vinblastine and GM-CSF as a treatment strategy for metastatic kidney cancer. It's a Phase II trial aiming to see how effective this mix is at stopping tumor growth by using drugs that prevent cell division alongside agents that may boost the immune system's ability to fight cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions related to immune stimulation such as fever and chills; effects from chemotherapy like nausea and hair loss; lowered blood counts leading to increased infection risk; fatigue; possible liver enzyme elevation; and other non-specific symptoms like headaches or muscle pains.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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My heart is healthy and I don't have severe heart problems.
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My kidney cancer cannot be removed by surgery and has spread.
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My cancer has not spread to my brain.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My creatinine level is below 1.5 mg/dL.
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My cancer can be measured or seen on tests.
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My lung function tests are normal.
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I have had skin cancer or early-stage cancer that did not spread.
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
Find a Location
Who is running the clinical trial?
Hope Cancer Institute, Inc.Lead Sponsor
3 Previous Clinical Trials
142 Total Patients Enrolled
Raj Sadasivan, MD, PhDStudy ChairHope Cancer Institute, Inc.
3 Previous Clinical Trials
142 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.My liver enzymes are within the required range.My heart is healthy and I don't have severe heart problems.I have had more than one hormone therapy in the last month.My kidney cancer cannot be removed by surgery and has spread.My cancer has not spread to my brain.I can take care of myself and am up and about more than 50% of my waking hours.My creatinine level is below 1.5 mg/dL.My surgery status is not a factor for this trial.I have had more than one biologic therapy in the last 4 weeks.My cancer can be measured or seen on tests.My lung function tests are normal.I have had skin cancer or early-stage cancer that did not spread.I have had more than one chemotherapy session in the last 4 weeks.I haven't had radiation therapy in the last 4 weeks or on my entire tumor.I am not pregnant or breastfeeding, use birth control, and have normal thyroid levels.
Research Study Groups:
This trial has the following groups: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.
Does this drug have the FDA's blessing?
"While there is some evidence to support the safety of this treatment, it is only in Phase 2 trials. This means that there is no efficacy data to support its use."
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