A phase I trial of recombinant human gamma interferon (IFN-gamma 4A) in patients with advanced malignancy.

Abstract

We report a Phase I study in 39 cancer patients of the tolerance and biologic activity of 47 intravenous (i.v.), intramuscular (i.m.), and subcutaneous (s.c.) treatments with recombinant methional gamma interferon (IFN-gamma 4A) which most closely resembles the natural material produced by T lymphocytes. Patients were treated with IFN-gamma 4A 5 days a week for 2 weeks. After a 2-week rest period, patients were placed on the same dose of drug three times a week. The most common side effects--fever, chills, malaise, myalgias, and nausea and vomiting--were seen with all routes of administration. Reversible increases in hepatic transaminase and decrease in granulocytes counts were seen. The dose-limiting toxicities observed were malaise and orthostatic hypotension. The maximum tolerated dose was 500-1,000 micrograms/M2/day. The t1/2 of IFN-gamma 4A in the circulation was 20 min after i.v. injection. No blood levels were detected after i.m. or s.c. injection. Antibody against IFN-gamma 4A increased in three patients. A complete response was observed in one patient with pulmonary metastases from renal cell carcinoma.

• Authors: R Perez, A Lipton, H A Harvey, M A Simmonds, P J Romano, S L Imboden, G Giudice, M R Downing, N K Alton
• Journal: Journal of biological response modifiers (J Biol Response Mod) Vol. 7 Issue 3 Pg. 309-17 (Jun 1988) ISSN: 0732-6580 [Print] United States
• PMID: 3134513 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• interferon gamma-4A
• Interferon-gamma

Topics

• Adult
• Aged
• Drug Evaluation
• Female
• Humans
• Injections, Intramuscular
• Injections, Subcutaneous
• Interferon-gamma (therapeutic use)
• Male
• Middle Aged
• Neoplasms (drug therapy)
• Recombinant Proteins (therapeutic use)