- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016133
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in patients with completely resected stage II or III adenocarcinoma of the colon.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III).
Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after surgical resection.
Beginning 10-17 days after the third vaccination, patients with stage III disease receive adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every 28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1 month after the completion of chemotherapy.
Patients are followed at 90 days and 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Allentown, Pennsylvania, United States, 18105-1556
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
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Virginia
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Fairfax, Virginia, United States, 22031
- Inova Fairfax Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael G Hanna Jr., PhD, Intracel
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Adjuvants, Immunologic
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Vaccines
- Leucovorin
- Calcium
- Levoleucovorin
- BCG Vaccine
Other Study ID Numbers
- INTRACEL-ASI-2002
- CDR0000068597 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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