Cytokine refractory Renal cell carcinoma
Conditions
Interventions
Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin for 11 days. Patients then re
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically confirmed renal cell carcinoma who had undergone nephrectomy 2) Patients with Stage IV (any T, any N, M1) 3) Patients who received cytokine therapy resulted in failure and without molecular target drugs 4) Patients who had evaluable metastasis on CT three months before the start of treatment, whose tumor doubling time before treatment was evaluable and no indication of resection. 5) ECOG performance status 0-1 and age between 20 to 80-years old. 6) Life expectancy >= 6 months 7) Leukocyte count >=3,000/mm*3 ANC >= 1,500/mm*3 Platelet count >=100,000/mm*3 Serum bilirubin >= 1.5 mg/dL AST/ALT >= 2.5 times normal Serum creatinine >= 1.7 mg/dL LDH>= 1.5 times normal 8) Patients who voluntarily provided written consent to participate in this trial after having been thoroughly briefed and informed of its nature were eligible for enrollment.
Exclusion criteria
Exclusion criteria: 1) No current treatment with any anti-cancer drugs 2) No brain metastasis, No hypercalcemia that require medication, No C-reactive protein with an infectious disease that requires medication, No active infection with hepatitis virus or HIV, No current treatment with steroids, No poorly controlled DM or heart failure or arrhythmia, No autoimmune disease and interstitial pneumonia, No other malignancy, No bone of organ transplant recipient, Not pregnant nor nursing, No mental disorder 3) Other patients judged to be ineligible by the attending investigators were also excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate: The best overall responses is defined by the RECIST criteria. The target lesions were scanned using helical CT at lease 6 weeks interval during the clinical trial. The disease control rate was determined the proportion of CR+PR+SD. | — |
Countries
Japan
Contacts
Public ContactHirohito Kobayashi
Tokyo Women's Medical University Department of Urology
Outcome results
None listed