AA SU011248 TREATMENT PROTOCOL FOR PATIENTS WITH CYTOKINE- REFRACTORY METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS AND MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Histopathologically confirmed renal cell carcinoma with metastase
2. Must be ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2 or 3 SU011248 protocols for patients having RCC are open to enrollment at the institution).
3. Judged by the treating physician to have the potential to derive clinical benefit from SU011248 treatment.
4. Male or female, 18 years of age or older.
5. If previously treated for metastatic RCC, the resolution of all acute toxic effects or prior system therapy, radiotherapy or surgical procedure to NCI CTCAE Vrsion 3.0 grade less/equal to 1
6. Adequate organ function as defined by the following criteria:
•Total serum bilirubin less/equal to 2 x ULN (patients with Gilbert’s disease exempt)
•Serum transaminases <5 x ULN
•Serum creatinine less/equal 2 x ULN
•Absolute neutrophil count (ANC) major/equal to 1000/mL without growth factor support
•Platelets major/equal to 75,000/mL
•Hemoglobin major/equal to 8.0 g/dL
7. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
8. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
9. AS required by local regulations, e.g. United Kingdom, ECOG performance status of 0, 1 or 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Current treatment in another therapeutic clinical trial
2. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication
3. Previous treatment on a SU011248 trial except for those patients who received IFN-aipha therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-aipha inolerant.
4. Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.
5. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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