Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
- Conditions
- Cervical Cancer
- Registration Number
- NCT00003017
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
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
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
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
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
Beth Israel Deaconess Medical Center🇺🇸Boston, Massachusetts, United States