Stage IV Melanoma Clinical Trial
Official title:
Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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