Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT00016133
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage II or III primary adenocarcinoma of the colon
* Completely resected within the past 28-35 days, at which time tumor tissue is harvested for vaccine production
* No residual or metastatic disease
* No more than 1 malignant invasive primary colon cancer
* No tumor originating in the rectum (i.e., inferior tumor margin must not be at or below the peritoneal reflection)
* No perforated tumors
PATIENT CHARACTERISTICS:
Age:
* 21 to 85
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10.0 g/dL
Hepatic:
* Bilirubin normal
* SGOT normal
* Alkaline phosphatase normal
* No severe hepatic disease that would preclude study
Renal:
* Creatinine less than 1.5 times upper limit of normal
* No severe renal disease that would preclude study
Cardiovascular:
* No prosthetic cardiac valves
* No recent vascular prosthesis
* No postsurgical cardiovascular complication
* No severe cardiovascular disease that would preclude study
Pulmonary:
* No postsurgical pulmonary complication
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No insulin-dependent diabetes mellitus
* No severe systemic disease that would preclude study
* No congenital or acquired immune deficiency disease
* No history of chronic ulcerative colitis, Crohn's disease, Gardner's syndrome, or Turcot's syndrome
* No ileus
* No other prior malignancy except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* No ongoing infection requiring systemic antibiotics
* No severe postoperative complication that would preclude study
* Carcinoembryonic antigen normal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No other concurrent investigational immunotherapy
Chemotherapy:
* No prior systemic chemotherapy
* No other concurrent investigational chemotherapy
Endocrine therapy:
* No concurrent steroids
Radiotherapy:
* No prior radiotherapy
* No concurrent investigational radiotherapy
Surgery:
* See Disease Characteristics
* No concurrent investigational surgery
Other:
* At least 3 weeks since prior systemic antibiotic therapy of more than 5 days duration (excluding topical antibiotics or perioperative prophylactic antibiotics)
* No concurrent cytotoxic immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00016133
Study Brief:
Protocol Section:
NCT00016133