[Phase I-II trial of gene therapy with tag-7 modified autologous tumor cells in patients with metastatic solid tumors].
A prospective (phase I-II) trial was undertaken to study the efficacy and toxicity of gene therapy with tag 70-modified autologous tumor cells in 32 patients with metastatic renal cell carcinoma (RC) (5) and melanoma (MBL) (27) treated at the Institute's Clinic (2001-2003). Resected material was reduced to cell culture, which was transfected with tag 70 gene and devitalized by irradiation. Immune blotting was used for gene expression. Clinical and immunological effectiveness was evaluated in 22 patients (MBL--17 and RC--5) who received 1-6 injections (3 on the average). Full course of vaccination was given to 8 (MBL--6 and RC--2). No complete or partial response was reported while least regression (50%) was registered in a case of RC metastatic to the lung. According to CT and ultrasound evidence, stabilization was achieved in 5 (23.8%) (MBL--4 and RC--1). Relapse-free period was 6.5+/-3.5 months beginning from the start of treatment. The vaccine was well tolerated while DHT reaction was observed in 47.6% (10 out of 17) of primary immunized patients. A trend of increased content of T- and B-cells in peripheral blood and intensified functional activity was established.
Moiseenko
V M
VM
Danilov
A O
AO
Baldueva
I A
IA
Danilova
A B
AB
Tiukavina
N V
NV
Larin
S S
SS
Kiselev
S L
SL
Orlova
R V
RV
Semenova
A I
AI
Turkevich
E A
EA
Shchelkina
L A
LA
Anisimov
V V
VV
Gafton
G I
GI
Kochnev
V A
VA
Barchuk
A S
AS
Kanaev
S V
SV
Khanson
K P
KP
Georgiev
G P
GP
D000328:Adult; D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000235:genetics; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D018572:Disease-Free Survival; D005260:Female; D015316:Genetic Therapy / Q000009:adverse effects; D006801:Humans; D007680:Kidney Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D012878:Skin Neoplasms / Q000473:pathology / Q000628:therapy*; D014162:Transfection
D019496:Cancer Vaccines