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Human melanoma gene therapy: from animal studies to clinical trials

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Mackiewicz A., Kapcinska M., Laciak M., Malicki J., Murawa P., Nowak, Sibilska E., Wiznerowicz M., Breborowicz D., Lange A., Hawley R. G.

Based on preclinical studies clinical protocol for immuno-gene therapy of human melanoma was designed in our Department.In January 1995, phase I clinical trial was initiated. Until now 5 patients with IV clinical degree of melanoma received geentic vaccine acco9rding to the following schedule: 4 injections in two weeks intervals, 3 injections in one month intervals and 3 injections in two month intervals.During therapy no toxic effects were observed.Induction of specific and non-specific anti-melanoma response was observed.Currently the trial enters phase II. Optimization of doses and immunization schedule as well as verification of patients eliglibility will be carried out.Moreover, clinical effcts of applied therapy will be monitored.

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1 Biotechnologia

1 1996

1 Breborowicz D.

1 Hawley R. G.

1 Kapcinska M.

1 Laciak M.

1 Lange A.

1 Mackiewicz A.

1 Malicki J.

1 Murawa P.

1 Nowak

1 Sibilska E.

1 Wiznerowicz M.

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Human melanoma gene therapy: from animal studies to clinical trials