Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix
OBJECTIVES: I. Determine the response rates, duration of response, and survival in women
with advanced, recurrent, or inoperable cervical cancer treated with interleukin-12. II.
Determine the toxic effects of systemic interleukin-12 in these patients. III. Correlate
response to therapy and survival with the presence or absence of human papilloma virus
(HPV), and the specific subtype of HPV, in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (yes vs no). Patients
receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5.
Treatment continues every 21 days in the absence of unacceptable toxicity or disease
progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years,
and then annually thereafter.
PROJECTED ACCRUAL: A total of 78 patients (39 per stratum) will be accrued for this study
within 26 months.
Primary Purpose: Treatment
Scott Wadler, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|University of Rochester Cancer Center||Rochester, New York 14642|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Vanderbilt Cancer Center||Nashville, Tennessee 37232-6838|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|
|Hunterdon Regional Cancer Center||Flemington, New Jersey 08822|