OncoVAX® is the first cancer therapy that both prevents cancer recurrence and
addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase
IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's
own cancer cells to mobilize the body's immune system to prevent the return of colon
cancer following surgery.
Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.
Patients must have undergone curative resection and have no evidence of residual or metastatic disease.
Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.
Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.
Patients with more than one malignant primary colon cancer will be excluded.