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Cancer Vaccine
Immunotherapy for Kidney Cancer
Phase 1
Waitlist Available
Led By Johannes Vieweg, M.D.
Research Sponsored by National Center for Research Resources (NCRR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with metastatic RCC following resection of the primary renal tumor (Pathologic diagnosis and staging of the disease will be completed at time of surgery)
Patients must have a performance status of 0 or 1 according the Eastern Cooperative Oncology Group (ECOG) criteria and must have an estimated life expectancy of 6 months and more
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study the feasibility and toxicity of escalating doses of dendritic cells transfected with autologous renal cell carcinoma RNA (DC(DCRCC-RNA)). Secondary endpoints will assess the ability of DCRCC-RNA to induce tumor-specific immune responses and the anti-tumor effects by clinical response criteria, duration, and overall survival.
Who is the study for?
This trial is for adults with metastatic renal cell carcinoma who've had the primary tumor removed and can visit Duke University Medical Center for follow-up. They should have a life expectancy over 6 months, good blood counts, and normal kidney/liver function. Pregnant/nursing women, recent surgery patients, those treated with certain therapies within 6 weeks, or individuals with autoimmune diseases or other serious illnesses are excluded.Check my eligibility
What is being tested?
The study tests different doses of dendritic cells transfected with the patient's own kidney cancer RNA to see if they're safe and can trigger an immune response against the cancer. It also looks at how well this treatment works in shrinking tumors and improving survival rates over two years.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include typical reactions to immunotherapies such as flu-like symptoms, injection site reactions, fatigue, fever, chills or more serious immune-related issues due to activation of the body's defense system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to remove a kidney tumor and it has spread.
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I can care for myself and doctors expect me to live 6 months or more.
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My kidney and liver tests are within normal limits.
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?
National Center for Research Resources (NCRR)Lead Sponsor
537 Previous Clinical Trials
317,016 Total Patients Enrolled
Duke UniversityOTHER
2,358 Previous Clinical Trials
3,420,069 Total Patients Enrolled
Johannes Vieweg, M.D.Principal Investigator
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a complete kidney removal surgery.I have not taken steroids or other immune-suppressing drugs in the last 6 weeks.I haven't had any cancer except for minor skin cancers or early-stage bladder cancer in the last 5 years.I cannot undergo leukapheresis due to poor vein access.I had surgery to remove a kidney tumor and it has spread.I can receive blood transfusions to meet the study requirements.I do not have any active infections or complications that would make treatment risky.I can care for myself and doctors expect me to live 6 months or more.I haven't had major surgery or cancer treatments in the last 6 weeks and have recovered from any side effects.My kidney and liver tests are within normal limits.My calcium levels are high or I have symptoms of high calcium, but I am receiving treatment for it.I have brain metastases, confirmed by a CT or MRI scan.I have a history of autoimmune disease like lupus or multiple sclerosis.
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 this research project accepting seniors of 65 years and above?
"The enrolment criteria for this medical trial mandates that participants must be at least 18 years old and not exceed the age of 65."
Answered by AI
What safeguards are in place to ensure the safety of those partaking in this treatment?
"The safety of the intervention is presumed to be low, as it's only been tested in Phase 1 trials; thus, our team at Power has assigned a score of one."
Answered by AI
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