Phase 2 trial of interferon-beta as second-line treatment of ovarian cancer, fallopian tube cancer, or primary carcinoma of the peritoneum.
OBJECTIVE
The protocol was designed to examine the biological effects and clinical activity of interferon-beta in patients with platinum/taxane-resistant ovarian cancer.


METHODS
Patients with resistant ovarian and fallopian tube cancers and primary peritoneal carcinoma were treated with recombinant human interferon-beta (Rebif, Serono International) at doses ranging from 6 to 24 million international units (MIU)/day, based on their tolerance to therapy. Levels of IP-10, an interferon-inducible protein, were measured in the serum to evaluate the biological effects of the drug. Also, the peripheral blood mononuclear cells and serum were examined for the induction of previously described novel regulators of interferon-induced death.


RESULTS
Eighteen patients were treated, of whom 9 (50%) could be treated at the highest dose level (24 MIU). The major toxicities were fever, chills and fatigue. The median duration of therapy was 6 weeks (range 1-22). No objective responses were observed. IP-10 levels were significantly increased, compared with baseline, at 2, 4, and 6 weeks after initiation of therapy (p < 0.01).


CONCLUSIONS
Recombinant human interferon-beta produced a definite biological effect in the serum of treated patients, but this outcome was not translated into any clinically observable or meaningful impact on the disease process.
Cleveland Clinic Taussig Cancer Center, and the Departments of Hematology/Medical Oncology, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. markmam@ccf.org
Maurie
M
Markman
Jerome
J
Belinson
Kenneth
K
Webster
Kristine
K
Zanotti
Bei
B
Morrison
Barbara
B
Jacobs
Ernest
E
Borden
Daniel
D
Lindner
D000368:Aged; D002277:Carcinoma / Q000188:drug therapy*; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011994:Recombinant Proteins; D017211:Treatment Failure; D016896:Treatment Outcome
D007370:Interferon Type I; D011994:Recombinant Proteins