Title

Testing Interleukin-12 to Determine Its Potential in Treating Advanced Cervical Cancer (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group, through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

Interleukin-12 is an experimental drug that enhances the body’s disease-fighting ability and kills some types of cancer cells. The purpose of this phase II trial was to test the anticancer effect of Interleukin-12 in treating cervical cancer that has advanced, returned or cannot be treated with surgery and to evaluate the side effects of this treatment.

Results

While interleukin-12 enhanced patients’ ability to fight some viruses associated with cervical cancer, it did not slow, stop or decrease cancer growth. The study showed that interleukin-12 is not a promising therapy for advanced, recurrent or inoperable cervical cancer.

Start Date

July 17, 1997

Stop Date

May 8, 2001

Number of Participating Patients

29

Eligibility Requirements

Patients had measurable cervical cancer that could not be treated with conventional therapy or that had returned or not been stopped by previous radiation or surgery.

Study Design

Patients received one dose of interleukin-12 to help their bodies get used to the drug. Two weeks later, each patient received daily injections of the interleukin-12 in a vein for five days. The five daily injections were repeated every three weeks for a total of 16 injections.

Side Effects

The most frequent side effects were anemia, liver problems, fever, nausea, and lowered susceptibility to infection.

References

Wadler S, Levy DE, Frederickson HL, Falkson CI, Wang Y, Weller E, Burk RD, Ho G, Kadish A. A Phase II Trial of Interleukin-12 in Patients with Advanced Cervical Cancer: Clinical and Immunologic Correlates. Eastern Cooperative Oncology Group Study E1E96. Gynecol Oncol 2004 Mar;92(3):957-64. (E1E96) [Manuscript published 3/15/2004]

National Cancer Institute Patient Summary

http://www.cancer.gov/clinical_trials/view_clinicaltrials.aspx?version=patient&cdrid=65597

Reviewed by

Donna Levy, ECOG Biostatistician; Robert Catalano, PharmD; Bruce Giantonio, MD, University of Pennsylvania Abramson Cancer Center; Cheryl K. Rutledge, BSN, Indiana University Cancer Center; Mary Lou Smith, ECOG Patient Representative

Released August 16, 2005 (Revised July 18, 2006)