The FDA has authorized TVAX Biomedical to perform phase II/III clinical trials to test the safety and efficacy of TVAX Immunotherapy as a treatment for grade III/IV astrocytomas and for stage IV renal cell carcinomas under IND-BB-13135. Currently authorized clinical trials are listed below.
GRADE III AND IV ASTROCYTOMA TRIALS
Study Title:Phase
IIa study of TVAX Immunotherapy using patients with recurrent grade III/IV astrocytomas
to assess the effects of increasing the cancer cell vaccination dose and the
number of vaccinations on toxicity and efficacy.
Study Title:Phase IIa
study to assess the safety and efficacy of TVAX Immunotherapy delivered
immediately following primary surgery and conformal radiotherapy in patients
with recently diagnosed grade III or grade IV astrocytoma.
METASTATIC RENAL CELL CARCINOMA TRIALS
Study Title:Phase IIa study using
patients with recurrent stage IV renal cell carcinoma to assess the effects of
increasing the cancer cell vaccination dose and the number of vaccinations on
the toxicity and efficacy of TVAX Immunotherapy.
Study Title:Phase IIa study to assess
the safety and efficacy of TVAX Immunotherapy delivered immediately following
surgery in patients with recently diagnosed stage IV renal cell carcinoma.