A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 weeks
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients are given three injections once per week for three weeks, followed by a booster shot after six months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether OncoVAX can help keep colon cancer from coming back after surgery. It is for people with Stage II colon cancer. OncoVAX uses a person's own cancer cells to help the immune system fight cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Stage II colon cancer: Stage IIA, IIB, or IIC.
- Have had surgery to remove the cancer, with no signs of cancer left behind or spread to other parts of the body.
- Have a normal CEA blood test after surgery. CEA is a marker linked to cancer. If it was high before surgery, it must return to normal within 21 days after surgery and before assignment to a study group.
Who can't join
- Have had radiation treatment or chemotherapy.
- Have had any earlier cancer, except cured basal cell or squamous cell skin cancer, or cured carcinoma in situ of the cervix (cancer limited to the surface cells).
- Have more than one separate cancer that started in the colon.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
FL
- Halifax Health Medical Center · Port Orange, FL 32127Ammar Hemaidan, MD · Study contactAmmar Hemaidan, MD · Principal investigatorMore trials in Port Orange