Stage II Colon Cancer
Conditions
Brief 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.
Detailed 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 trial published in The Lancet showed that OncoVAX cut the risk of recurrence by 61% in patients with Stage II colon cancer. The primary endpoint is Disease-Free Survival: defined as the time from curative surgery to the objective test confirming tumor recurrence or death due to any cause. The secondary endpoints are Overall Survival and Recurrence-Free-Interval. An interim analysis will be performed at a significance level of 0.005 once 2/3 of anticipated events have occurred, resulting in a significance level of 0.0483 at the end of the study. A total of 550 patients is planned, randomized 1:1 to receive OncoVAX® plus surgery (n=275) or surgery alone (n=275).
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
Sponsors
Vaccinogen Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to Five Years | Defined as the time from randomization to death due to any cause |
| Recurrence-Free Interval | Up to Five Years | Defined as the time from randomization to the first objective test confirming tumor recurrence |
Countries
United States
Contacts
CONTACTMichael G Hanna, PhD
CONTACTLaTonjia S Wallace, MS, MBA
STUDY_CHAIRMichael G Hanna, Jr, PhD
Vaccinogen Inc
STUDY_DIRECTORHerbert C. Hoover, MD
Vaccinogen Inc
Outcome results
None listed