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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00075660
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed renal cell carcinoma
* Locally recurrent OR metastatic disease
* Incurable by standard therapy
* Clinically and/or radiologically measurable disease
* At least 1 unidimensionally measurable lesion\* at least 20 mm by x-ray, physical exam, or non-spiral CT scan OR at least 10 mm by spiral CT scan
* If the sole site of measurable disease is in a previously irradiated field, there must be documented disease progression at that site NOTE: \*Bone lesions are not considered measurable disease
* No documented brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No glucose-6-phosphate dehydrogenase (G6PD) deficiency\* NOTE: \*Screening for G6PD deficiency is required for patients of African, Asian, or Mediterranean descent
Hepatic
* Bilirubin normal
* AST or ALT no greater than 2.5 times upper limit of normal (ULN)
Renal
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 50 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic congestive heart failure
* No unstable angina
* No active cardiomyopathy
* No cardiac arrhythmia
* No uncontrolled hypertension
Pulmonary
* No pulmonary disease requiring oxygen
Immunologic
* HIV negative
* No known hypersensitivity to compounds of similar chemical or biological composition to 3-AP (Triapine®)
* No active uncontrolled or serious infection
* No immunodeficiency
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor with no evidence of disease for at least 5 years
* No history of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude giving informed consent or complying with study requirements
* No active peptic ulcer disease
* No other serious illness or medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 3 months since prior interferon for advanced or recurrent disease
* No other prior immunotherapy for advanced or recurrent disease
* No prior gene therapy
Chemotherapy
* No prior systemic chemotherapy for advanced or recurrent disease
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered
Surgery
* At least 2 weeks since prior major surgery
Other
* No prior investigational anticancer agents
* No other concurrent anticancer agents or therapy
* No other concurrent investigational therapy
* No concurrent anticoagulants
* Concurrent nontherapeutic warfarin or heparin allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00075660
Study Brief:
Protocol Section:
NCT00075660