Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix

Inclusion Criteria

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