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Cancer Vaccine
Dendritic Cell Immunotherapy for Prostate 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
The patient has a histologic or clinically confirmed prostate adenocarcinoma (Stage D1-D3 metastatic with regional lymphatic, bone, visceral, or soft tissue metastases) excluding transitional cell and small cell carcinomas of prostate origin
The patient has adequate renal and hepatic function with serum creatinine < 2.5mg/dl and bilirubin < 2.0 mg/dl
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the feasibility and safety of administering escalating doses of tumor RNA transfected dendritic cells to patients with metastatic prostate cancer, in order to evaluate the ability of the cells to induce tumor-specific immune responses.
Who is the study for?
This trial is for men with metastatic prostate cancer (stages D1-D3) who have a life expectancy over 6 months, good physical health, and normal blood, kidney, liver, and coagulation tests. They can continue hormone therapy but must stop other treatments before joining. Men with autoimmune diseases, serious illnesses like severe heart or lung conditions, active infections including HIV or hepatitis, another cancer type besides skin cancer or superficial bladder cancer cannot join.Check my eligibility
What is being tested?
The study is testing the safety of a new treatment where patients' own immune cells (dendritic cells) are modified in the lab to attack their prostate cancer by using RNA from their tumors. The goal is to see if these modified cells can boost the body's ability to fight the tumor and improve patient outcomes.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions at injection sites, flu-like symptoms such as fever and chills due to immune activation; fatigue; possible autoimmunity since this involves stimulating the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prostate cancer that has spread to other parts of my body, but it's not small cell or transitional cell cancer.
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My kidney and liver are functioning well.
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I can understand and sign the consent form as per the guidelines.
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I am mostly able to care for myself and carry out normal activities.
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
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Who is running the clinical trial?
Duke UniversityOTHER
2,358 Previous Clinical Trials
3,420,069 Total Patients Enrolled
42 Trials studying Prostate Cancer
96,794 Patients Enrolled for Prostate Cancer
National Center for Research Resources (NCRR)Lead Sponsor
537 Previous Clinical Trials
317,016 Total Patients Enrolled
1 Trials studying Prostate Cancer
Johannes Vieweg, M.D.Principal InvestigatorDuke University
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo leukapheresis due to poor vein access.I have prostate cancer that has spread to other parts of my body, but it's not small cell or transitional cell cancer.I have a history of autoimmune diseases like lupus or multiple sclerosis.I've had a 4-week break (12 weeks if treated with 89-Strontium) from any cancer treatment and recovered from side effects.I have another cancer besides non-melanoma skin cancer or superficial bladder cancer.I currently have an infection, such as a UTI, HIV, or hepatitis.I am not currently on steroids or immunosuppressants, or it has been 6 weeks since I stopped.I have a serious illness like severe heart, lung, or liver disease that makes treatment risky.My kidney and liver are functioning well.I stopped taking my hormone therapy for prostate cancer 4 weeks ago due to rising PSA levels.I can understand and sign the consent form as per the guidelines.I am mostly able to care for myself and carry out normal activities.I have brain metastases from my cancer, previously treated or new.I am on hormone therapy for cancer with testosterone levels below 50 mg/l.
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 the age restriction for this research limited to those below fifty-five?
"As per the regulations of this trial, only those 18 years old or above and below 65 are eligible for enrollment."
Answered by AI
What health risks are associated with this treatment plan?
"Due to the experimental nature of this treatment, with limited evidence demonstrating safety and efficacy, its score is 1 on a scale from 1-3."
Answered by AI
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