A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OncoVAX and Surgery, Surgery.
- Who it may be relevant to
- Registry conditions: Stage II Colon Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Overview
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
- Biological 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 - Procedure Surgery
Surgical resection of Stage II colon cancer
Primary outcome measures
- Disease-Free Survival [Time frame: Up to Five years]
Secondary outcome measures (2)
- Overall Survival [Time frame: Up to Five Years]
- Recurrence-Free Interval [Time frame: Up to Five Years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Halifax Health Medical Center — Port Orange
Identifiers
NCT: NCT02448173 · ASI-2005-04