OncoVAX 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
Surgery: Surgical resection of Stage II colon cancer
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 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.
Primary outcome measure(s)
Disease-Free Survival — Up to Five years Defined as time from randomization to the date of the first objective test confirming tumor recurrence or death due to any cause
Trial sites (1)
Facility
City
Region
Status
Halifax Health Medical Center
Port Orange
Florida
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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