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

Phase 2
18 Years
Not Enrolling
Cervical Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott Wadler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

August 2005

Related Keywords:

  • Cervical Cancer
  • stage IV cervical cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
University of Rochester Cancer Center Rochester, New York  14642
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Northern New Jersey Hackensack, New Jersey  07601
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Hunterdon Regional Cancer Center Flemington, New Jersey  08822