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Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer Clinical research trials and Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer  Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
For Condition: Stage 4 rectal cancer,recurrent rectal cancer,recurrent colon cancer,stage 4 colon cancer,recurrent renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): St. Luke's Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of fluorouracil combined with biological therapy in treating patients who have metastatic kidney or colorectal cancer.
Details: OBJECTIVES: I. Determine the safety of fluorouracil and interleukin-12-primed activated T cells (12ATC) with sargramostim (GM-CSF) and interferon alfa in patients with metastatic renal cell cancer or colorectal cancer. II. Determine the maximum tolerated dose of 12ATC in this patient population. III. Determine the clinical response of patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC). Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and undergo leukopheresis on day 6 to obtain peripheral blood mononuclear cells (PBMC). Patients treated at dose level 3 also undergo leukopheresis on day 7. The PBMC are treated with monoclonal antibody anti-CD3, interleukin-12 and interleukin-2 to form 12ATC. Patients receive chemo/immunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and GM-CSF and interferon alfa SC on days 17, 19, 21, 24, 26, and 28. Patients receive 12ATC IV over 15-30 minutes on days 31, 34, 38, 41, 45, and 48 and interferon alfa SC on days 35, 42, and 49. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic renal cell carcinoma or colorectal carcinoma Failed prior standard or salvage therapy OR Ineligible for standard therapy due to concurrent illness OR Declined standard therapy - Bidimensionally measurable disease (by CT scan or MRI) outside prior irradiation port unless documented disease progression after radiotherapy - No untreated or unstable treated brain metastasis --Prior/Concurrent Therapy-- - See Disease Characteristics - Biologic therapy: More than 1 month since prior biologic therapy or immunotherapy - Chemotherapy: More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - Endocrine therapy: At least 4 weeks since prior steroid therapy or steroid-containing compounds; At least 2 weeks since prior topical or inhaled steroids; No concurrent steroids - Radiotherapy: More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: More than 3 months - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3; Total granulocyte count at least 2,000/mm3; Hemoglobin at least 10 g/dL; No coagulation disorders such as thrombophlebitis Hepatic: Bilirubin no greater than 2.5 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); Alkaline phosphatase less than 3 times ULN; PT/PTT no greater than 1.5 times control; Hepatitis B surface antigen negative - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No active ischemia and/or ejection fraction less than 45%; No unstable angina; No uncontrolled congestive heart failure - Pulmonary: FEV1 or FVC greater than 65% of predicted; No uncontrolled pulmonary embolism - Other: No other prior malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix; No active systemic infection; No autoimmune disease; No uncontrolled thyroid abnormalities; No other major medical illness; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnHanson, Study Chair, St. Luke's Medical Center
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Additional Information:
Study ID Numbers: CDR0000068588; STLMC-IMM-0001,NCI-V01-1656
Study Start Date: January 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016042
Other Recurrent Renal Cell Cancer Studies:
1. SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
2. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
3. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
4. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
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