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Clinical phase II trial of recombinant dna interferon (interferon alfa 2b) in patients with metastatic malignant melanoma
Author(s) -
Dorval Thierry,
Palangie Thao,
Jouve Michel,
GarciaGiralt Emilio,
Israel Lucien,
Falcoff Ernesto,
Schwab Denis,
Pouillart Pierre
Publication year - 1986
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19860715)58:2<215::aid-cncr2820580202>3.0.co;2-p
Subject(s) - medicine , melanoma , recombinant dna , interferon alfa , metastatic melanoma , interferon , clinical trial , oncology , alpha interferon , cancer research , immunology , biochemistry , chemistry , gene
Twenty‐four patients with historically proven metastatic malignant melanoma were included in a Phase II trial of human DNA recombinant interferon (rDNA IFNα2). They were given 10 × 10 6 IU of IFNα2 subcutaneously three times a week until progression of disease or major intolerance developed. Twenty‐ two patients were evaluable for toxicity and response. General manifestations of intolerance were seen in all the patients. Hematologic toxicity was seen in six patients and therapy had to be interrupted in one patient. Mild liver toxicity was seen in most patients after 2 weeks of treatment. These manifestations disappeared within 2 weeks after treatment was discontinued. A partial response was seen in four cases lasting 2, 4, 4, and 5 months, respectively. There were two complete responses (one skin, one lymph node metastasis) lasting 20 and 6 weeks, respectively. These results indicate a potential role for rDNA IFNα2 in treating patients with metastatic malignant melanoma. However, further trials are required to determine the optimal dose and schedule of administration and modalities of combination. Cancer 58:215–218, 1986.