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Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer. Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer  Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,adenocarcinoma of the rectum,stage 4 colon cancer,adenocarcinoma of the colon
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines 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. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy. PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.
Details: OBJECTIVES: - Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma. - Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms. - Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once weekly for 3 weeks. Two weeks after the third vaccine administration, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive ALVAC-CEA-B7.1 vaccine and chemotherapy as in arm I. - Arm III: Patients receive chemotherapy as in arm I. After completion of chemotherapy, patients with partial or complete response may receive ALVAC-CEA-B7.1 vaccine SC once weekly on weeks 1-3 and 6. PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic colorectal adenocarcinoma - No clinically active CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - More than 6 months Hematopoietic: - Lymphocyte count at least 1,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST/ALT less than 3 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present) - No hepatocellular dysfunction - No cirrhosis Renal: - Creatinine less than 2.5 mg/dL Cardiovascular: - No uncontrolled coronary artery disease - No symptomatic congestive heart failure Pulmonary: - No uncontrolled chronic obstructive lung disease Gastrointestinal: - No unsolved bowel obstruction or subobstruction - No uncontrolled Crohn's disease - No ulcerative colitis - No concurrent chronic diarrhea Immunologic: - HIV negative - No immunocompromised patients - No diagnosis of altered immune function, including: - Lupus erythematosus - Sjogren's syndrome - Scleroderma - Myasthenia gravis - Goodpasture's disease - Addison's disease - Hashimoto's thyroiditis - Active Graves' disease - No known allergy to egg products or neomycin - No prior adverse reaction to tetanus toxoid-containing vaccines Other: - No significant comorbid medical function - No uncontrolled infection - No unstable diabetes mellitus - No uncontrolled thyroid function abnormalities - No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix - No other medical illness or mental status that would preclude study participation - No prior severe toxicity to adjuvant chemotherapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior CEA-directed immunotherapy - No other concurrent immunotherapy Chemotherapy: - At least 6 months since prior adjuvant chemotherapy - No prior chemotherapy for metastatic disease - No other concurrent chemotherapy Endocrine therapy: - No concurrent daily use of systemic steroids - No concurrent nonsubstitutional hormonal therapy Radiotherapy: - No prior radiotherapy to more than 50% of all nodal groups - No concurrent radiotherapy except for palliative purposes involving less than 20% of bone marrow reserve Surgery: - No prior major organ allograft - Recovered from prior surgery Other: - At least 28 days since prior investigational products - No other concurrent investigational products
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardKaufman, Study Chair, Columbia Presbyterian Medical Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35243
United States
Scranton Hematology-Oncology
Scranton, Pennsylvania, 18510
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000069082; FCCC-01015,NCI-G01-2033,CPMC-14534,CPMC-BB-IND-9911,APL-COL13
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027833
Other Adenocarcinoma Of The Rectum Studies:
1. Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
2. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
3. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
4. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other adenocarcinoma of the rectum Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
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