Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
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|ClinicalTrials.gov Identifier: NCT00003017|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : June 21, 2013
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|
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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix|
|Study Start Date :||July 1997|
|Actual Study Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003017
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, New Jersey|
|Hunterdon Regional Cancer Center|
|Flemington, New Jersey, United States, 08822|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|University of Rochester Cancer Center|
|Rochester, New York, United States, 14642|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Vanderbilt Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Scott Wadler, MD||Albert Einstein College of Medicine, Inc.|