RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells in the cervix. PURPOSE: Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer 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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
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NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States