Phase
Condition
Kidney Cancer
Renal Cell Carcinoma
Urothelial Tract Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic renal cell adenocarcinoma, meeting 1 of the following criteria:
More than 1 metastatic site and good performance status (Karnofsky score 80-100%)
Sole metastatic site with Karnofsky score = 80%
Karnofsky 90% or 100% not eligible
No combination of several metastatic sites and liver metastases and a time interval from primary tumor to metastases of < 1 year
Nonmeasurable disease and/or few numbers of lesions must be confirmed histologically and as progressive disease
The following metastases are allowed:
Lung with or without mediastinum lymph nodes
Bone
Pleura (solid or liquid with positive cytology)
Thoracic lymph nodes
Abdominal lymph nodes
Superficial lymph nodes
Liver
Subcutaneous skin/tissue
Contralateral kidney
Nephrectomy site
Other organs
Prior metastases allowed provided the following criteria are met:
Evidence of progressive disease within the past 3 months
Metastases evaluated by noninvasive methods
No evidence of active brain metastases
Prior brain metastases allowed provided all of the following criteria are met:
Disease is stable
Reductive therapy (surgery or radiotherapy) completed at least 3 weeks prior to study entry
Metastases have not progressed (confirmed by CT scan or MRI)
No concurrent corticosteroids required
PATIENT CHARACTERISTICS:
See Disease Characteristics
Creatinine < 1.8 mg/dL
Hematocrit ≥ 30%
WBC ≥ 4,000/mm^3
Platelet count ≥ 120,000/mm^3
Bilirubin normal
LVEF ≥ 50%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No HIV positivity
No severe infection requiring antibiotic therapy
No chronic hepatitis
No severe lung, liver or kidney condition that would preclude study treatment
No hepatitis B surface antigen positivity
No severe neuropsychiatric condition or epilepsy
No serious thromboembolitic disorder
No severe cardiac dysfunction (e.g., congestive heart failure, uncontrolled hypertension, serious arrhythmia, or coronary disease)
No other prior or concurrent primary malignancies except for basal cell skin cancer or carcinoma in situ of the cervix
No geographical, psychological, or familial condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
More than 6 weeks since prior wide-field radiotherapy
No prior systemic chemotherapy
No prior organ transplantation
No prior cytokines
No concurrent hormonal therapy
No concurrent anticancer chemotherapy
No concurrent corticosteroids
No other concurrent immunotherapy
No other concurrent investigational agents or therapies