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:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT00278395
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma that is either metastatic or inoperable
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-based therapy OR new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 based treatment
* Patients who have failed up to 4 lines of prior immunotherapy or biological therapy allowed
* No known brain metastases or leptomeningeal disease
* Stable brain metastases or curatively resected brain metastases without neurologic dysfunction for ≥ 6 months allowed
* ECOG performance status 0-2 OR Karnofsky 70-100%
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 50 mL/min
* Total bilirubin within normal limits
* AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
* No history of active malignancy (other than renal cell carcinoma) within the past 3 years other than nonmelanomatous skin cancer, in situ breast cancer, or in situ cervical cancer
* No history of allergic reactions to compounds of similar chemical or biological composition to vorinostat (SAHA)
* No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* No psychiatric illness or social situation that would preclude study compliance
* No clinically significant hypercalcemia
* No significant traumatic injury within the past 21 days
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No gastrointestinal disease resulting in an inability to take oral medication
* No requirement for IV alimentation
* No active peptic ulcer disease
* Recovered from prior therapy
* Prior nephrectomy or resection of metastatic lesions allowed provided full surgical recovery has occurred
* No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin)
* No radiotherapy within the past 4 weeks
* No valproic acid for at least 2 weeks prior to study enrollment
* No prior surgical procedures affecting absorption
* No major surgery within the past 21 days
* No concurrent antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00278395
Study Brief:
Protocol Section:
NCT00278395