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SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment 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 SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment Clinical research trials and SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment 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 SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment. SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment 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 SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment clinical trial. Test subjects typically receive the most effective healthcare possible for their SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment 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 > "S" Clinical Trials Conditions > SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment  SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens. II. Determine the changes in tumor perfusion in patients treated with this regimen. III. Determine the time to progression and survival in patients treated with this regimen. PROTOCOL OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 3-6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic renal cell carcinoma - Prior removal of primary tumors - Bidimensionally measurable disease; Bone-only disease is not considered measurable - Progressive disease following no more than 2 prior biologic therapy (e.g., interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) or fluorouracil-containing (single-agent or in combination therapy) regimens - No known history of CNS metastasis unless all of the following are true: Previously treated; Neurologically stable; No requirement for IV steroids or anticonvulsants; No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI - Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; No other concurrent anti-cancer biologic therapy - Chemotherapy: See Disease Characteristics; No concurrent anti-cancer chemotherapy - Endocrine therapy: See Disease Characteristics - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No sole indicator lesion within the previously irradiated port; No concurrent anti-cancer radiotherapy - Surgery: See Disease Characteristics; At least 4 weeks since prior major surgery and recovered; At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease; No concurrent surgery for cancer - Other: No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study --Patient Characteristics-- - Age: 16 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGPT no greater than 2.5 times upper limit of normal; PT and PTT normal; Fibrinogen normal D-Dimer assay normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: See Surgery; No active congestive heart failure; No uncontrolled angina; No myocardial infarction or severe/unstable angina within the past 6 months; No uncontrolled hypertension; No uncompensated coronary artery disease on electrocardiogram or physical examination; No severe peripheral vascular disease; No deep vein or arterial thrombosis within the past 3 months - Pulmonary: No pulmonary embolism within the past 3 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent serious infection; No overt psychosis, mental disability, or incompetence; No diabetes mellitus; No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix; No hypersensitivity or allergic reaction to paclitaxel
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherLogothetis, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068424; MDA-ID-99291,NCI-1290
Study Start Date: November 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009919
Other Stage 4 Renal Cell Cancer Studies:
1. Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
2. ZD 1839 in Treating Patients With Metastatic Kidney Cancer
3. Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
4. BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
5. Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma (Kidney Cancer)
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
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