Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer 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.
DISEASE CHARACTERISTICS: Histologically proven stage IV or recurrent squamous cell,
 adenosquamous, or adenocarcinoma of the uterine cervix including: Lung, liver, lymph node,
 or skin metastases OR Retroperitoneal disease OR Other advanced measurable disease OR
 Positive paraaortic lymph nodes Measurable disease that is beyond the scope of conventional
 radiation therapy or surgery, or recurrent after radiation therapy or surgery Measurable,
 recurrent disease within a previously irradiated field must have increased in size by 100%
 on at least 2 successive scans, MRI, or physical examinations

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not
 specified Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least
 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
 the upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine
 no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No New
 York Heart Association class III/IV heart disease No uncontrolled congestive heart failure
 or angina Pulmonary: No chronic obstructive pulmonary disease Gastrointestinal: No evidence
 of active gastrointestinal bleeding No active peptic ulcer disease No inflammatory bowel
 disease Other: Normal diet required No known active infections HIV negative AIDS-related
 complex (ARC) negative No substance abuse or psychiatric problems No evidence of autoimmune
 disease No other prior invasive malignancy except resected basal cell or squamous cell skin
 cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
 contraception

 PRIOR CONCURRENT THERAPY: Biologic therapy: 1 prior biologic therapy allowed At least 4
 weeks since prior biologic therapy Chemotherapy: 1 prior adjuvant chemotherapy regimen
 allowed 1 prior chemotherapy regimen for advanced disease allowed At least 4 weeks since
 prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent steroid
 therapy No concurrent megestrol acetate Radiotherapy: See Disease Characteristics No
 concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior
 surgery