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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT00098618
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed renal cell carcinoma
* Locally advanced or metastatic disease
* All histologic subtypes allowed
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No known brain metastases or leptomeningeal disease
* Performance status - ECOG 0-2
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No bleeding diathesis
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance ≥ 60 mL/min
* No uncontrolled hypertension
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of sensitivity to E. coli-derived products
* No history of severe depression
* No active infection requiring antibiotics
* No seizure disorder requiring antiepileptic medication
* No medical condition likely to require systemic corticosteroids
* No autoimmune disorder that could result in life-threatening complications
* No other uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* No more than 1 prior biologic response modifier regimen
* At least 4 weeks since prior biologic response modifiers
* No prior interferon alfa
* No prior chemotherapy
* At least 4 weeks since prior radiotherapy to non-index lesions
* Prior radiotherapy to index lesion allowed provided irradiated lesion progressed ≥ 20% in diameter
* At least 2 weeks since prior major surgery
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent therapeutic anticoagulation therapy
* Concurrent prophylactic anticoagulation, such as low-dose warfarin, for venous or arterial access device allowed provided PT, PTT, and INR are normal
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00098618
Study Brief:
Protocol Section:
NCT00098618