Study of Patients With Stage IV Malignant Melanoma Using PS-341 (Bortezomib, Velcade) and Interferon-alpha-2b in Malignant Melanoma

Phase 1 Completed 16 enrolled Ohio State University Comprehensive Cancer Center

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety, tolerability and dose limiting toxicities (DLTs) of VELCADE when administered in combination with interferon-alpha-2b (IFN-α-2b) to patients with metastatic malignant melanoma.

Timeline

Start: 2006-01
Primary completion: 2010-10
Completion: 2013-04

Publications

Results Markowitz J, Luedke EA, Grignol VP, Hade EM, Paul BK, Mundy-Bosse BL, Brooks TR, Dao TV, Kondalasula SV, Lesinski GB, Olencki T, Kendra KL, Carson WE 3rd. A phase I trial of bortezomib and interferon-alpha-2b in metastatic melanoma. J Immunother. 2014 Jan;37(1):55-62. doi: 10.1097/CJI.0000000000000009.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1.3 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1.6 mg/m2	Intravenous
Subject	interferon alfa-2b	Protein / enzyme biologic	5e+06 iu	Subcutaneous

Study of Patients With Stage IV Malignant Melanoma Using PS-341 (Bortezomib, Velcade) and Interferon-alpha-2b in Malignant Melanoma

Summary

Timeline

Publications

Drugs

Indications