Immunization with interleukin-2 transfected melanoma cells. A phase I-II study in patients with metastatic melanoma.
The safety, tolerance and clinical effects of immunization with irradiated, allogeneic melanoma cells that express high levels of HLA-A1 and -A2 and secrete IL-2 after transfection with the Interleukin-2 gene, will be assessed in HLA-A1 or HLA-A2 positive melanoma patients with metastatic disease. As a pilot, the first 5-10 patients, if no immediate regression of tumor lesions are observed, will in addition to immunization with these allogeneic tumor cells receive recombinant IL-2 in relatively low doses during three consecutive weeks on an outpatient basis. If no clinical remissions are induced in these first 5-10 patients, subsequent 5-10 patients will receive the same dose of melanoma cells without additional rIL-2. Thereafter the dose of injected melanoma cells will be increased in every following 5-10 patients, but all subsequent patients will receive only IL-2 producing, allogeneic tumor cells, without the addition of rIL-2.
Osanto
S
S
Brouwenstÿn
N
N
Vaessen
N
N
Figdor
C G
CG
Melief
C J
CJ
Schrier
P I
PI
D002985:Clinical Protocols; D015316:Genetic Therapy; D006801:Humans; D007167:Immunotherapy; D007376:Interleukin-2 / Q000008:administration & dosage / Q000235:genetics / Q000627:therapeutic use*; D008545:Melanoma / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D012878:Skin Neoplasms / Q000235:genetics / Q000473:pathology / Q000628:therapy*; D014162:Transfection; D014407:Tumor Cells, Cultured / Q000637:transplantation; D014611:Vaccination
D007376:Interleukin-2