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SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer Clinical research trials and SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer. SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer clinical trial. Subjects often receive the most expert healthcare possible for their SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer  SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer
SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer
For Condition: stage 4 renal cell cancer,renal clear cell carcinoma,recurrent renal cell cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Clinical trial to study the effectiveness of SU011248 in treating patients who have cytokine-refractorymetastaticrenal cell cancer.
Details: OBJECTIVES: Primary - Determine the antitumor efficacy of SU011248 in patients with cytokine-refractory metastatic renal cell cancer. Secondary - Determine duration of tumor control in patients treated with this drug. - Determine overall survival of patients treated with this drug. - Determine the safety and tolerability of this drug in these patients. - Correlate plasma concentration with efficacy and safety parameters of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral SU011248 once daily on weeks 1-4. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 100 patients 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 renal cell cancer - Metastatic disease - Clear cell histology - Unidimensionally measurable disease - At least 1 malignant tumor mass that is at least 20 mm by conventional radiographic techniques or MRI OR at least 10 mm by spiral CT scan - The following are not considered measurable: - Bone lesions - Ascites - Peritoneal carcinomatosis or miliary lesions - Pleural or pericardial effusions - Lymphangitis of the skin or lung - Cystic lesions - Irradiated lesions - Failed 1, and only 1, prior cytokine therapy with interleukin-2 (IL-2), interferon alfa (IFN-A)*, or a combination of IL-2 and IFN-A* - Radiographic evidence of disease progression during or within 9 months after completion of therapy NOTE: *Prior pegylated interferon alfa may be used instead of IFN-A - Underwent prior nephrectomy - No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis - No new evidence of brain or leptomeningeal disease on screening CT scan or MRI - No papillary, collecting duct, or chromophobe type renal cell carcinoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9.0 g/dL - No ongoing hemorrhage of grade 3 Hepatic - AST and ALT 2.5 times upper limit of normal (ULN) (5 times ULN if due to underlying malignancy) - Bilirubin 1.5 times ULN Renal - Creatinine 1.5 times ULN - Calcium 12.0 mg/dL Cardiovascular - LVEF lower limit of normal by MUGA - No ongoing cardiac dysrhythmias grade 2 - No atrial fibrillation of any grade - No prolongation of the QTc interval to > 450 msec for males OR > 470 msec for females - No hypertension that cannot be controlled with medications - None of the following within the past 12 months: - Myocardial infarction - Severe/unstable angina - Symptomatic congestive heart failure - Cerebrovascular accident or transient ischemic attack - Pulmonary embolism - Deep vein thrombosis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation - Amylase and lipase 1.5 times ULN - Adrenocorticotrophic hormone stimulation test normal - HIV negative - No AIDS-related illness - No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Recovered from prior cytokine therapy - No other prior cytokine-based therapy - No concurrent biological response modifiers - No concurrent immunotherapy Chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy to the only site of measurable disease - Concurrent palliative radiotherapy allowed Surgery - See Disease Characteristics - At least 4 weeks since prior surgery and recovered - More than 12 months since prior coronary/peripheral artery bypass graft - No concurrent surgery to the only site of measurable disease Other - At least 4 weeks since prior systemic therapy - No other prior systemic therapy (except IFN-A, IL-2, or a combination of IFN-A and IL-2) - No concurrent participation in another clinical trial - No other concurrent approved or investigational anticancer treatment - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Robert Motzer 646-422-4312
Additional Information:
Study ID Numbers: CDR0000360862; MSKCC-04001,PFIZER-A6181006
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082849
Other Stage 4 Renal Cell Cancer Studies:
1. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
2. BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
3. SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer
4. Erlotinib in Treating Patients With Advanced Kidney Cancer
5. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
SU011248 in Treating Patients With Cytokine-Refractory Metastatic Renal Cell Cancer
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