A phase I clinical trial of recombinant human tumor necrosis factor given daily for five days

1989 ◽  
Vol 23 (3) ◽  
Author(s):  
PatrickJ. Creaven ◽  
DeanE. Brenner ◽  
J.Wayne Cowens ◽  
RobertP. Huben ◽  
RichardM. Wolf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tumor Necrosis Factor ◽  
Phase I ◽  
Tumor Necrosis ◽  
Human Tumor ◽  
Phase I Clinical Trial ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

Phase I clinical trial of recombinant human tumor necrosis factor

1987 ◽  
Vol 20 (2) ◽  
Author(s):  
PatrickJ. Creaven ◽  
JohnE. Plager ◽  
Sherry Dupere ◽  
RobertP. Huben ◽  
Hiroshi Takita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tumor Necrosis Factor ◽  
Phase I ◽  
Tumor Necrosis ◽  
Human Tumor ◽  
Phase I Clinical Trial ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

scholarly journals A phase I clinical trial of recombinant human tumor necrosis factor

Cancer ◽  
1988 ◽  
Vol 62 (12) ◽  
pp. 2467-2471 ◽  
Author(s):  
Edward T. Creagan ◽  
John S. Kovach ◽  
Charles G. Moertel ◽  
Stephen Frytak ◽  
Larry K. Kvols
Keyword(s):  
Clinical Trial ◽  
Tumor Necrosis Factor ◽  
Phase I ◽  
Tumor Necrosis ◽  
Human Tumor ◽  
Phase I Clinical Trial ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

Recombinant human tumor necrosis factor administered as a five-day continuous infusion in cancer patients: phase I toxicity and effects on lipid metabolism.

1988 ◽  
Vol 6 (2) ◽  
pp. 344-350 ◽  
Author(s):  
M L Sherman ◽  
D R Spriggs ◽  
K A Arthur ◽  
K Imamura ◽  
E Frei ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Phase I ◽  
Continuous Infusion ◽  
Tumor Necrosis ◽  
Human Tumor ◽  
High Density Lipoproteins ◽  
Enzyme Linked Immunosorbent Assay ◽  
Pharmacokinetic Studies ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

Recombinant human tumor necrosis factor (rH-TNF) is a cytotoxic monokine with pleiotropic effects. A phase I trial of rH-TNF was initiated using a five-day continuous intravenous (IV) infusion repeated every 28 days. Thirty-eight courses of therapy were administered to 19 patients. The starting dose was 5 X 10(4) U/m2/d, with escalations to 1.0 X 10(5), 2.0 X 10(5), 2.4 X 10(5), and 3.0 X 10(5) U/m2/d. Systemic side effects, including fever, chills, hypotension, fatigue, anorexia, and headaches, were mild and self-limiting. At the maximum tolerated dose of 3.0 X 10(5) U/m2/d, dose-limiting hematologic toxicity was manifested by transient thrombocytopenia and leukopenia. Elevated bilirubin levels were also seen at the higher dose levels. Lipoprotein analysis demonstrated that the five-day treatment with rH-TNF was associated with decreases in high-density lipoproteins, as well as increases in triglycerides and very-low-density lipoproteins. Pharmacokinetic studies using an enzyme-linked immunosorbent assay (ELISA) test indicated plasma rH-TNF levels less than 0.2 U/mL. The recommended phase II dose of rH-TNF administered as a five-day continuous infusion is 2.4 X 10(5) U/m2/d.

Phase I clinical trial of recombinant human tumor necrosis factor in children with refractory solid tumors: a Pediatric Oncology Group study.

1993 ◽  
Vol 11 (11) ◽  
pp. 2205-2210 ◽  
Author(s):  
W L Furman ◽  
D Strother ◽  
K McClain ◽  
B Bell ◽  
B Leventhal ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Phase I ◽  
Solid Tumors ◽  
Tumor Necrosis ◽  
Human Tumor ◽  
Rest Period ◽  
Supplemental Oxygen ◽  
Maximum Tolerated Dose ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

PURPOSE A phase I study was undertaken to determine the toxicity and maximum-tolerated dose (MTD) of recombinant human tumor necrosis factor (rTNF) in children. PATIENTS AND METHODS Twenty-seven patients with recurrent or refractory solid tumors were enrolled on the study. rTNF was administered daily for 5 days by 30-minute intravenous (IV) infusion, and doses were escalated in cohorts of three to six patients. Courses were repeated after a 9-day rest period, if toxicity was tolerable. Daily doses ranged from 100 to 350 micrograms/m2. RESULTS Most courses were associated with grade I/II fever, rigors, nausea, or vomiting. Three patients experienced moderate dyspnea that responded to supplemental oxygen. All abnormalities resolved on discontinuation of the infusion. One patient had a cardiac arrest 90 minutes after receiving the first dose of rTNF and died 10 days later of related complications. In two other patients, rTNF was discontinued due to persistent grade IV hypotension. Toxicities were not consistently related to dose and no cumulative effects were noted. The dose-limiting toxicity was transient hepatic dysfunction, which occurred in three of six patients receiving 350 micrograms/m2; this toxicity was rapidly reversed on discontinuation of the rTNF. One patient, whose non-Hodgkin's lymphoma had recurred after bone marrow transplantation, had a partial response. Disease was stabilized in two patients. CONCLUSION We recommend that phase II testing proceed at a dose of 300 micrograms/m2/d on the schedule described.

Phase I study of recombinant human tumor necrosis factor

1987 ◽  
Vol 20 (3) ◽  
pp. 223-229 ◽  
Author(s):  
Kiyoji Kimura ◽  
Tetsuo Taguchi ◽  
Ichiro Urushizaki ◽  
Ryuzo Ohno ◽  
Osahiko Abe ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Phase I ◽  
Phase I Study ◽  
Tumor Necrosis ◽  
Human Tumor ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

Phase I study of recombinant human tumor necrosis factor ? in advanced malignant disease

1989 ◽  
Vol 29 (2) ◽  
Author(s):  
T. Moritz ◽  
N. Niederle ◽  
J. Baumann ◽  
D. May ◽  
E. Kurschel ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Phase I ◽  
Phase I Study ◽  
Tumor Necrosis ◽  
Malignant Disease ◽  
Human Tumor ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor

GMP production and characterization of leucine zipper-tagged tumor necrosis factor-related apoptosis-inducing ligand (LZ-TRAIL) for phase I clinical trial

2014 ◽  
Vol 740 ◽  
pp. 722-732 ◽  
Author(s):  
Jing Jiang ◽  
Xiaobin Liu ◽  
Leixiu Deng ◽  
Peipei Zhang ◽  
Guangjun Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tumor Necrosis Factor ◽  
Phase I ◽  
Tumor Necrosis ◽  
Leucine Zipper ◽  
Phase I Clinical Trial ◽  
Necrosis Factor ◽  
Gmp Production

Phase I Studies of Recombinant Human Tumor Necrosis Factor in Patients with Malignant Disease

2015 ◽  
pp. 183-188 ◽  
Author(s):  
Volker Diehl ◽  
Michael Pfreundschuh ◽  
H. Tilman Steinmetz ◽  
Michael Schaadt
Keyword(s):  
Tumor Necrosis Factor ◽  
Phase I ◽  
Tumor Necrosis ◽  
Malignant Disease ◽  
Human Tumor ◽  
Human Tumor Necrosis Factor ◽  
Phase I Studies ◽  
Necrosis Factor

Granulocytopenia in Cancer Patients Treated in a Phase I Trial with Recombinant Human Tumor Necrosis Factor

1991 ◽  
Vol 10 (2) ◽  
pp. 84-95 ◽  
Author(s):  
T. F. Logan ◽  
S. S. Kaplan ◽  
J. L. Bryant ◽  
M. S. Ernstoff ◽  
J. R. Krause ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Phase I ◽  
Cancer Patients ◽  
Tumor Necrosis ◽  
Phase I Trial ◽  
Human Tumor ◽  
Human Tumor Necrosis Factor ◽  
Necrosis Factor
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