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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00003656
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic renal cell carcinoma
* Bidimensionally measurable disease
* No active brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 3 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* No coagulation disorders
Hepatic:
* Bilirubin less than 1.5 mg/dL
* SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal
* No clinically significant hepatic disease, including autoimmune hepatitis
Renal:
* Creatinine less than 2 mg/dL OR
* Creatinine clearance greater than 50 mL/min
* No clinically significant renal disease
Cardiovascular:
* No clinically significant cardiac disease
* No thrombophlebitis
Pulmonary:
* No severe debilitating pulmonary disease
* No pulmonary embolism
Other:
* No history of diabetes mellitus prone to ketoacidosis
* No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study
* No thyroid abnormalities that hinder maintaining thyroid function at the normal range
* No severe infection
* No severe malnutrition
* No clinically significant retinal abnormalities
* No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder
* No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior biological response modifier therapy or immunotherapy
Chemotherapy:
* No more than 1 prior chemotherapy regimen
Endocrine therapy:
* No concurrent steroids
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* At least 4 weeks since prior major surgery
Other:
* No prior retinoid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00003656
Study Brief:
Protocol Section:
NCT00003656