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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00093405
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma
* Papillary OR clear cell histology
* If other histologies are present, clear cell or papillary must be predominant
* Metastatic disease
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No brain metastases unless previously treated with radiotherapy or surgery AND asymptomatic with no active brain metastases detectable by CT scan or MRI for ≥ 6 months
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* AST and ALT ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 2.0 times ULN
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No severe valvular disease
Pulmonary
* No severe debilitating pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No allergy to egg or egg products
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
* No active or ongoing infection requiring IV antibiotics
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 1 prior cytokine-based regimen
* No concurrent biologic therapy
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgery
Other
* Recovered from prior therapy
* No more than 1 prior non-cytokine-based regimen
* No other prior systemic treatment regimens
* No other concurrent cytotoxic therapy
* No other concurrent anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00093405
Study Brief:
Protocol Section:
NCT00093405