A Phase II Study of Ipilimumab Plus Isolated Limb Infusion with Melphalan and Dactinomycin to Treat Advanced Unresectable Melanoma of the Extremity

Protocol
10-101
Full Title
A Phase II Trial of The Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity
Phase
II
Purpose

Isolated limb infusion (ILI) is a treatment approach for melanoma in which chemotherapy drugs are directly administered into an arm or leg with the disease. The standard chemotherapy drugs used in ILI include melphalan and dactinomycin. However, not all patients respond to this treatment, and many of those who do respond eventually experience a recurrence of melanoma elsewhere in the body.

Investigators in this study want to see if adding the drug ipilimumab to ILI with melphalan and dactinomycin can improve outcome. Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism.

An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.

View a video for more information about this approach.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIB, IIIC, or IV melanoma in an arm or leg that cannot be surgically removed.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Charlotte Ariyan at 212-639-6280 or Dr. Mary Sue Brady at 212-639-8347.

Disease(s)
Melanoma
Locations
Related Diseases