Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT01158534
Eligibility Criteria:
Criteria
* Patients must have histologically-confirmed metastatic renal cell carcinoma
* Patients must have 3+ (on a scale of 0 to 3+) COX-2 staining in \>= 10% of the RCC tumor cells from baseline tumor tissue
* Patients must not have received any prior cytokine therapy for renal cell carcinoma
* Patients may have received any number of prior non-cytokine systemic therapies for metastatic RCC
* Patients must have undergone nephrectomy (radical or partial)
* All patients must be at least 2 weeks from prior systemic therapy, radiation or major surgery
* Patients must have measurable disease per RECIST criteria
* ECOG performance status 0 or 1
* Leukocytes \>= 3,000/mL
* Absolute neutrophil count \>= 1,500/mL
* Platelets \>= 75,000/mL
* Total bilirubin =\< 1.5x institutional upper limit
* AST(SGOT)/ALT(SGPT) =\< 2.5x institutional upper limit
* Creatinine =\< 2.0x institutional upper limit
* No significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris requiring nitrate therapy, uncontrolled dysrhythmias or recent cardiovascular event (defined as any of the following within the previous 6 months: TIA/CVA, MI, vascular surgery)
* Ability to understand and the willingness to sign a written informed consent document
* Patients with any untreated CNS metastases are excluded from this clinical trial; patients who have undergone surgery and/or radiation for CNS metastases are eligible for enrollment if they do not have CNS metastases that have not been treated, are at least 2 weeks from treatment of CNS metastases without evidence of CNS disease progression (stable CT scan or MRI) and are off steroids; all patients must undergo an MRI or infused CT scan of the brain prior to enrollment
* Patients may not be concurrently receiving any other investigational agents
* Pregnant women; women of childbearing potential must have a negative pregnancy test prior to enrollment and use adequate contraception while on study and for one month thereafter
* Concurrent systemic steroid therapy is prohibited (inhaled or topical steroids as well as physiologic replacement doses of steroids are permitted)
* Patients with a history of a severe allergic reaction (defined as a grade 4 rash, a reaction requiring steroids or epinephrine or any degree of airway compromise) to sulfonamide or sulfonamide derivatives drugs are excluded; this includes, but is not limited to, sulfonamide antibiotics such as sulfadiazine, sulfamethoxazole, sulfisoxazole and sulfacetamide and sulfonamide derivatives such as celecoxib, valdecoxib, diuretics (HCTZ, furosemide), sulfonylureas, dorzolamide and sumatriptan
* Karnofsky \>= 70%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01158534
Study Brief:
Protocol Section:
NCT01158534