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Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer Clinical research trials and Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer  Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Recruiting
Sponsor(s): Cleveland Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as fluorouracil work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. PURPOSE: Phase I/II trial to study the effectiveness of combining fluorouracil with the chemosensitizer suramin in treating patients who have metastaticrenal cell (kidney) cancer.
Details: OBJECTIVES: Primary - Determine the dose of suramin and fluorouracil that would result in plasma concentrations of suramin between 10-50 μM in patients with metastatic renal cell cancer. Secondary - Determine the preliminary efficacy of this regimen in these patients. - Determine the pharmacokinetics of low-dose suramin in these patients. Primary - Determine the objective response rate (complete response and partial response) in patients treated with this regimen. Secondary - Determine the time to tumor progression and progress rate at 3 and 6 months in patients treated with this regimen. OUTLINE: This is a dose-escalation phase I study followed by a phase II study. - Patients receive suramin IV over 30 minutes and fluorouracil IV on days 1, 8, 15, 22, 29, and 36. Cohorts of 3-6 patients receive escalating doses suramin and fluorouracil until the dose level allowing 10-50 μM of suramin into the patient's blood is determined without 2 or more of 6 patients experiencing dose-limiting toxicity. - Phase II: Patients receive suramin and fluorouracil (at the dose level determined in phase I) as in phase I. In both phases, courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 23-40 patients (6-12 for phase I and 17-28 for phase II) will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell cancer - Metastatic disease - Measurable or evaluable disease - Measurable disease required for phase II - No untreated CNS metastasis or CNS metastases progressing 4 weeks after prior radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9.0 g/dL Hepatic - AST 2.5 times upper limit of normal (ULN) - Alkaline phosphatase 5 times ULN - Bilirubin 1.5 mg/dL Renal - Creatinine 1.8 mg/dL - Calcium 11.0 mg/dL - No untreated hypercalcemia Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must be surgically sterile or use effective contraception - No uncontrolled diabetes mellitus - No known severe hypersensitivity to suramin - No other concurrent uncontrolled illness - No active or ongoing infection - No active autoimmune disease - No neuropathy grade 2 - No psychiatric illness or social situation that would preclude study compliance - No other malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF) Chemotherapy - No more than 2 prior chemotherapy regimens for renal cell cancer (phase II only) Endocrine therapy - No concurrent corticosteroid dose more than physiologic replacement levels Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Recovered from prior oncologic or other major surgery - At least 4 weeks since prior major surgery - No concurrent surgery Other - Recovered from all prior anticancer therapy other than alopecia (chronic toxicity < grade 2) - At least 4 weeks since prior systemic therapy - More than 30 days since prior investigational drugs - Concurrent bisphosphonates allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldBukowski, Study Chair, Cleveland Clinic Cancer Center
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Ronald Bukowski 216-444-6825
Additional Information:
Study ID Numbers: CDR0000363559; NCI-6036,CCF-6101
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083109
Other Stage 4 Renal Cell Cancer Studies:
1. Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
2. SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
3. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
4. Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
5. Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
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