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Immunotherapy
Lymphocyte Therapy for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status ECOG 0-2
Renal criteria: Creatinine no greater than 4.0 mg/dL, Calcium no greater than 12 mg/dL, No symptomatic hypercalcemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying a treatment for kidney cancer that uses a person's own lymphocytes.
Who is the study for?
This trial is for adults over 16 with stage III or IV kidney cancer that's been surgically removed. They should have no serious illnesses, infections, or organ dysfunction and not be pregnant. Participants must have stable vital signs and blood counts within specific ranges.Check my eligibility
What is being tested?
The study tests lymphocyte therapy where a patient's immune cells are treated with interleukin-2 and monoclonal antibody to fight kidney cancer more effectively when reintroduced into the body.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as fever, chills, fatigue; there might also be risks associated with infusing cells back into the body like infection or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
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My kidney function is within safe limits, and I don't have high calcium levels or symptoms.
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My liver functions are within normal limits and I don't have hepatitis B.
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I am older than 16 years.
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I don't have severe heart problems like recent heart attacks or heart failure.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Onset of recurrence as measured by Kaplan-Meier method at 5 years
Safety as measured by NCI Common Toxicity Criteria at completion of study
Survival as measured by Kaplan-Meier method at 5 years
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,764 Total Patients Enrolled
John P. Hanson, MDStudy ChairSt. Luke's Medical Center
7 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received a solid organ transplant.I am not receiving any other treatment after kidney removal surgery.My kidney cancer was surgically removed and confirmed by a lab test.I am able to get out of my bed or chair and move around.My kidney function is within safe limits, and I don't have high calcium levels or symptoms.My liver functions are within normal limits and I don't have hepatitis B.I haven't taken corticosteroids (except for breathing issues or adrenal insufficiency) in over a week.I am not currently on hormone therapy, except for postmenopausal replacement.It has been over 3 weeks since I had major surgery, such as kidney removal.I do not have nephrotic syndrome.I am older than 16 years.I don't have severe heart problems like recent heart attacks or heart failure.I am not currently on any immunotherapy treatments.I am not currently receiving chemotherapy.
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.
Is there still availability for participants in this clinical experiment?
"As per the information on clinicaltrials.gov, this trial is not enrolling participants presently. This particular study was initially posted in July 1994 and most recently updated December 2013; however, 423 other medical studies are currently seeking patients to fill their enrolment quotas."
Answered by AI
What level of risk do patients incur from this intervention?
"The safety of this therapy is estimated to be a 2 due to the Phase 2 nature of the trial, which has data validating its security but not yet demonstrating efficacy."
Answered by AI
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