Autologous Dendritic Cell Vaccine in Kidney Cancer
ConditionCarcinoma, Renal Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJodi Maranchie
About this trial
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.
Eligibility criteria
Qualifiers
Histologically proven clear cell renal cancer that is non-metastatic and amenable to surgical resection with no evidence of metastatic disease or lesions outside of the kidney.
18 years or older (male or female) with an ECOG performance status of 0 or 1.
Have serotype HLA-A2+ if receiving vaccine.
Capable of understanding and complying with the protocol requirements and have signed the informed consent document.
Disqualifiers
Current (within the preceding 6 weeks) treatment with systemic immunosuppressive agents including steroids except when they are administered as replacement therapy for endocrine dysfunction and do not exceed 10 mg prednisone or equivalent daily.
Known or suspected metastatic disease.
Active Hepatitis B or Hepatitis C infection or any other active infection requiring intravenous therapy.
Blood transfusion within two weeks prior to leukapheresis.
Trial design
Treatments tested in this trial
- Autologous alpha-DC1/TBVA vaccine
- Cabozantinib
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jodi Maranchie
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov