NCT00026143

Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma. 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. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the clinical response rates in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b. II. To estimate the progression-free survival in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b. SECONDARY OBJECTIVES: I. To measure serum levels of interferon-gamma. II. To measure levels of JAK-STAT signaling intermediates in patient PBMCs and tumor samples. III. To analyze interferon-alpha-induced STAT signaling in patient PBMCs. IV. To determine the expression of IFN-regulated genes in patient PBMCs and tumor tissues. V. To determine the pattern of gene expression induced by treatment with IL-12 and interferon-alpha using DNA microarray techniques in patient PBMCs. OUTLINE: This is a multicenter study. Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression. Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interleukin-12	Given IV
BIOLOGICAL	recombinant interferon alfa	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-10-01
• Primary completion: 2004-07-01
• First posted: 2003-01-27
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States