TY - JOUR
T1 - Phase I study of multiple dose intramuscularly administered recombinant gamma interferon
AU - Kurzrock, R.
AU - Quesada, J. R.
AU - Talpaz, M.
AU - Hersh, E. M.
AU - Reuben, J. M.
AU - Sherwin, S. A.
AU - Gutterman, J. U.
PY - 1986
Y1 - 1986
N2 - We report the results of a phase I study of the tolerance and biologic activity of intramuscularly (IM)-administered recombinant interferon-gamma (rIFN-γ). Forty-four patients with metastatic cancer were given rIFN-γ at doses ranging from 0.01 to 2.5 mg/m2/d for 42 days. The most common side effects were fever, flulike symptoms, night sweats, and granulocytopenia. The maximum tolerated dose was 0.5 mg/m2/d. Administration of rIFN-γ resulted in modulation of immune system functions, including induction of major histocompatibility complex-associated antigens on blood leukocytes, an increase in blood surface immunoglobulin-bearing B cell and natural killer (NK) cell number, and NK cell cytotoxicity. Serum lysozyme, determined as an estimate of tissue macrophage activity, also increased. Serum assays for antiinterferon antibodies were negative in all patients. Five of eight evaluable patients with lymphoproliferative disorders showed objective evidence of tumor regressison consisting of partial responses (two patients), and minor responses (three patients). These data suggest that further phase II studies of IM-administered rIFN-γ are indicated.
AB - We report the results of a phase I study of the tolerance and biologic activity of intramuscularly (IM)-administered recombinant interferon-gamma (rIFN-γ). Forty-four patients with metastatic cancer were given rIFN-γ at doses ranging from 0.01 to 2.5 mg/m2/d for 42 days. The most common side effects were fever, flulike symptoms, night sweats, and granulocytopenia. The maximum tolerated dose was 0.5 mg/m2/d. Administration of rIFN-γ resulted in modulation of immune system functions, including induction of major histocompatibility complex-associated antigens on blood leukocytes, an increase in blood surface immunoglobulin-bearing B cell and natural killer (NK) cell number, and NK cell cytotoxicity. Serum lysozyme, determined as an estimate of tissue macrophage activity, also increased. Serum assays for antiinterferon antibodies were negative in all patients. Five of eight evaluable patients with lymphoproliferative disorders showed objective evidence of tumor regressison consisting of partial responses (two patients), and minor responses (three patients). These data suggest that further phase II studies of IM-administered rIFN-γ are indicated.
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U2 - 10.1200/JCO.1986.4.7.1101
DO - 10.1200/JCO.1986.4.7.1101
M3 - Article
C2 - 3088221
AN - SCOPUS:0022542594
SN - 0732-183X
VL - 4
SP - 1101
EP - 1109
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 7
ER -