NCT00003017
Completed
Phase 2
Phase II Clinical Trial of Interleukin-12 in Patients With Advanced, Recurrent or Inoperable Carcinoma of the Cervix
ConditionsCervical Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Eastern Cooperative Oncology Group
- Locations
- 9
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
Study Sites (9)
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