Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
Up to 2 years
No
William Carson
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02816
NCT00026143
October 2001
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |