Vaccine Therapy in Treating Patients With Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Patients with minimal disease burden are eligible provided they meet one or more of the following criteria: Prior nephrectomy and completely resected metastases Favorable-risk group, as defined by all of the following criteria: Karnofsky 80-100% Hemoglobin ≥ 13 g/dL (male) or ≥ 12 g/dL (female) Corrected calcium ≤ 10 mg/dL Prior nephrectomy Serum lactate dehydrogenase ≤ 200 μ/L Prior nephrectomy with metastases confined to lung and/or small volume metastatic disease (< 3 cm) exclusive of bone and liver No spinal, epidural, or CNS lesions No bone, liver or brain disease PATIENT CHARACTERISTICS: Age 18 and over Performance status See Disease Characteristics Karnofsky 80-100% Life expectancy Not specified Hematopoietic See Disease Characteristics WBC ≥ 3,500/mm^3 Hemoglobin ≥ 12.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin < 2.0 mg/dL SGOT < 3.0 times upper limit of normal Renal See Disease Characteristics Creatinine ≤ 2.0 mg/dL OR Creatinine clearance ≥ 40 mL/min Cardiovascular No clinically significant cardiac disease No New York Heart Association class III or IV heart disease Pulmonary No severe debilitating pulmonary disease Other Fertile patients must use effective contraception No other active secondary malignancy within the past 5 years except non-melanoma skin cancer No infection requiring antibiotic treatment No narcotic- or steroid-dependent pain PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since prior chemotherapy Endocrine therapy At least 4 weeks since prior corticosteroid therapy Radiotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy to only measurable lesion Surgery See Disease Characteristics No concurrent surgery Other Recovered from all prior therapy No other concurrent anticancer therapy
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
human PSMA
mouse PSMA
Patients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.
Patients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.