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Proleukin® Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Principal Investigator: Janice Dutcher, MD
Time frame of study: Ongoing
Location of Study:

Mount Sinai Beth Israel
St.Luke's-Mount Sinai West


Continuum Cancer Research Program
(212) 844-6286


Proleukin® (the brand name of aldesleukin for injection), also commonly known as interleukin-2 or recombinant IL-2, was approved by US FDA in the1990s for treating adult patients with metastatic Renal Cell Carcinoma or metastatic melanoma. High dose IL-2 (HD IL-2) is the first immunotherapy approved for use as a single agent in the treatment of cancer.

The PROCLAIM Registry, is designed to create an observational database that will allow evaluations of the real world treatment patterns and trends involving High dose IL-2 effectiveness, tolerability, and other patient management outcomes in treating patients with metastatic renal cell carcinoma, metastatic melanoma or other malignancies in the United States.

The primary objective is to establish a standardized source of observational data that can be used to report and query patient care patterns, clinical outcomes and trends from HD IL-2 therapy in treating metastatic melanoma, metastatic renal cell carcinoma or other malignancies.

Eligibility and Treatment Plan:
Prospective Cohort:
• 18 years of age and older
• Planned to receive at least one course of HD IL-2 and must receive at least one dose of HD IL-2
• Given informed consent for participating in the Registry

Please call for more information.




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