Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003017

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Biological: recombinant interleukin-12	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 1997

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Hunterdon Regional Cancer Center	Flemington	New Jersey	United States	08822
3	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
4	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
5	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
6	University of Rochester Cancer Center	Rochester	New York	United States	14642
7	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
8	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213
9	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838