Actively Recruiting
Autologous Dendritic Cell Vaccine in Kidney Cancer
Led by Jodi Maranchie · Updated on 2025-05-04
42
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.
CONDITIONS
Official Title
Autologous Dendritic Cell Vaccine in Kidney Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven clear cell renal cancer that is non-metastatic and suitable for surgical removal with no signs of spread beyond the kidney.
- Age 18 years or older with an ECOG performance status of 0 or 1.
- Positive for HLA-A2 serotype if receiving the vaccine.
- Ability to understand and agree to study requirements and provide informed consent.
- Adequate organ and bone marrow function as shown by specific laboratory tests within 14 days before treatment, including minimum counts for neutrophils, white blood cells, and platelets; hemoglobin at or above 9 g/dL; liver enzymes and bilirubin within specified limits; serum albumin at or above 2.8 g/dl; clotting tests below 1.3 times the upper limit of normal; serum creatinine below 2.0 times upper limit or sufficient kidney clearance; and urine protein levels within set limits.
- Agreement to use medically accepted contraception during the study and for 4 months after treatment if sexually active and fertile.
- Female participants of childbearing potential must not be pregnant at screening and meet specific criteria to confirm menopausal status if applicable.
You will not qualify if you...
- Use of systemic immunosuppressive agents including steroids within the past 6 weeks, except low-dose replacement therapy.
- Known or suspected spread of cancer beyond the kidney.
- Active infections like Hepatitis B, Hepatitis C, or any infection needing intravenous therapy.
- Blood transfusion within two weeks before leukapheresis.
- Previous treatment with cabozantinib.
- Use of kinase inhibitors within two weeks before treatment.
- Use of any systemic anticancer therapy within four weeks before treatment.
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before treatment.
- Use of certain anticoagulants except specified low-dose aspirin or stable anticoagulation without brain metastases.
- Abnormal clotting test results above 1.3 times upper limit of normal within 7 days before treatment.
- Uncontrolled or recent serious illnesses such as severe heart failure, uncontrolled hypertension, recent strokes or blood clots, serious gastrointestinal conditions, significant bleeding, lung lesions, or major blood vessel involvement.
- Serious non-healing wounds or ulcers, symptomatic hypothyroidism, moderate to severe liver impairment.
- Major surgery within 2 weeks or minor surgery within 10 days before treatment without complete healing.
- Prolonged QT interval on ECG above 500 ms within 14 days before treatment.
- Pregnancy or breastfeeding.
- Inability to swallow tablets.
- Known allergy to study treatment components.
- Other active cancers requiring treatment except certain cured skin or superficial cancers.
- Any other condition considered a safety risk by the doctor.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UPMC Department of Urology
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
M
Morgan Pokora, RN
CONTACT
J
Jodi Maranchie, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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