PMID- 3134513
OWN - NLM
STAT- MEDLINE
DCOM- 19880818
LR  - 20111117
IS  - 0732-6580 (Print)
IS  - 0732-6580 (Linking)
VI  - 7
IP  - 3
DP  - 1988 Jun
TI  - A phase I trial of recombinant human gamma interferon (IFN-gamma 4A) in patients 
      with advanced malignancy.
PG  - 309-17
AB  - 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.
FAU - Perez, R
AU  - Perez R
AD  - Milton S. Hershey Medical Center, Pennsylvania State University, Hershey.
FAU - Lipton, A
AU  - Lipton A
FAU - Harvey, H A
AU  - Harvey HA
FAU - Simmonds, M A
AU  - Simmonds MA
FAU - Romano, P J
AU  - Romano PJ
FAU - Imboden, S L
AU  - Imboden SL
FAU - Giudice, G
AU  - Giudice G
FAU - Downing, M R
AU  - Downing MR
FAU - Alton, N K
AU  - Alton NK
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Biol Response Mod
JT  - Journal of biological response modifiers
JID - 8219656
RN  - 0 (Recombinant Proteins)
RN  - 0 (interferon gamma-4A)
RN  - 82115-62-6 (Interferon-gamma)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Drug Evaluation
MH  - Female
MH  - Humans
MH  - Injections, Intramuscular
MH  - Injections, Subcutaneous
MH  - *Interferon-gamma/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*drug therapy
MH  - Recombinant Proteins/therapeutic use
EDAT- 1988/06/01 00:00
MHDA- 1988/06/01 00:01
CRDT- 1988/06/01 00:00
PHST- 1988/06/01 00:00 [pubmed]
PHST- 1988/06/01 00:01 [medline]
PHST- 1988/06/01 00:00 [entrez]
PST - ppublish
SO  - J Biol Response Mod. 1988 Jun;7(3):309-17.