Clinical evaluation of liposomal tumor antigen vaccines in patients with stage-III melanoma.
In this study, we report the results of an active-specific immunotherapy phase I study using autologous tumor-associated antigens (TAA) incorporated within liposomal carriers in patients with metastatic malignant melanoma. A group of 13 patients were entered into the study and given subcutaneous (s.c.) injections of liposome-TAA preparations at 2- to 4-week intervals. Clinical and laboratory monitoring did not reveal any short- or long-term systemic or local toxicity. Three patients had a complete response, and two patients had a partial response (50% or greater size reduction in one or more tumor sites). The remaining eight patients showed no response with disease progression. Two of these eight patients are still undergoing treatment. The TAA preparations stimulated peripheral blood lymphocyte proliferation (PBL) in vitro in those patients exhibiting a clinical response: no such responses were observed in the nonresponder patients. NK cell activity did not correlate with PBL proliferation or clinical response status, whereas PBL cytostatic activity against heterologous melanoma tumor cells correlated with clinical responsiveness. This form of immunotherapy appears to be a safe and feasible candidate for a much larger phase I/II study.
Phillips
N C
NC
Montreal General Hospital Research Institute, Quebec, Canada.
Loutfi
A
A
A-Kareem
A M
AM
Shibata
H R
HR
Baines
M G
MG
D000328:Adult; D000368:Aged; D000951:Antigens, Neoplasm / Q000008:administration & dosage*; D004337:Drug Carriers; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D016233:Immunotherapy, Active; D007279:Injections, Subcutaneous; D007694:Killer Cells, Natural / Q000502:physiology; D008081:Liposomes; D008213:Lymphocyte Activation / Q000276:immunology; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008545:Melanoma / Q000276:immunology / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D014407:Tumor Cells, Cultured
D000951:Antigens, Neoplasm; D004337:Drug Carriers; D008081:Liposomes