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A phase I‐II trial of the combination of recombinant leukocyte a interferon and recombinant human interferon‐γ in patients with metastatic malignant melanoma
Author(s) -
Creagan Edward T.,
Loprinzi Charles L.,
Ahmann David L.,
Schaid Daniel J.
Publication year - 1988
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(19881215)62:12<2472::aid-cncr2820621203>3.0.co;2-g
Subject(s) - medicine , melanoma , concomitant , recombinant dna , interferon , biopsy , phases of clinical research , gastroenterology , oncology , immunology , clinical trial , cancer research , biochemistry , chemistry , gene
Twenty patients with advanced malignant melanoma received daily intramuscular recombinant leukocyte A interferon (rIFN‐αA, Roferon‐A, Hoffmann‐Laroche, Nutley, NJ) concomitant with recombinant human interferon‐γ (rIFN‐γ Genentech, South San Francisco, CA). During the first week or dose was 2 × 10 6 U/m 2 and the γ dose was 0.01 mg/m 2 with escalations, if clinically tolerable, during the second week to 5 × 10 6 U/m 2 and 0.025 mg/m 2 , respectively. Twelve patients received the escalated doses; subsequent granulocytopenia and a flu‐type illness were severe in four of the 12. We observed one partial response of MRI‐documented and biopsy‐confirmed osseous metastases for 7+ months. For all study participants, the median time to progression was 1 month with a median survival of 6 months. From the dose and schedule which we utilized, concurrent rIFN‐αA and rIFN‐γ provided little impact on advanced malignant melanoma.