A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Vaccinogen Inc
Summary
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.
Description
OncoVAX is an active specific immunotherapeutic (ASI) stimulating a patient's immune response to autologous (patient-specific) tumor cells. It is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer. Within 35 days following surgery, patients are immunized with OncoVAX to prevent disease recurrence, which is incurable and occurs in up to 35% of patients. Patients are given three injections once per week for three weeks, followed by a booster shot after six months. A previously completed Phase III tr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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 ba…
Interventions
- BiologicalOncoVAX and Surgery
OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer
- ProcedureSurgery
Surgical resection of Stage II colon cancer
Location
- Halifax Health Medical CenterPort Orange, Florida