A Pilot Study of Nelfinavir as a Treatment for Kaposi Sarcoma

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PAC Protocol: A Pilot Study of Nelfinavir for the Treatment of Kaposi Sarcoma (AMC 098)

Purpose

The purpose of this study is to assess the safety and effectiveness of a drug called nelfinavir for the treatment of Kaposi sarcoma. The U.S. Food and Drug Administration has approved nelfinavir as a treatment for HIV infection, but it has not yet been evaluated as a treatment for Kaposi sarcoma.

Nelfinavir has been shown to kill the Kaposi sarcoma-associated herpes virus (KSHV) that causes the disease, and it is safe when used at higher doses to treat other cancers. In this study, researchers will determine whether nelfinavir works better to shrink Kaposi sarcoma when the usual dose is followed by a higher dose, and whether this treatment approach causes any side effects. Another purpose of this study is to learn how well nelfinavir blocks the KSHV virus.

Patients in this study will take nelfinavir orally (by mouth), with the dosage increased if the Kaposi sarcoma does not respond or decreased if nelfinavir causes serious side effects.

Eligibility

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

  • Patients must have Kaposi sarcoma that is either previously untreated or persists despite prior treatment.
  • At least 4 weeks must pass between completion of prior chemotherapy or radiation therapy and entry into the study.
  • This study is open to both HIV-positive and HIV-negative patients.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Mark Dickson at 646-888-4164.

Protocol

18-422

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators