Cervical Cancer Clinical Trial
Official title:
Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix
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.
;
Primary Purpose: Treatment
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