NCT00003017

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interleukin-12

Timeline

• Start date: 1997-07-01
• Completion: 2005-08-01
• First posted: 2004-04-22
• Last updated: 2013-06-21

Locations

9 sites across 1 country: United States