A Phase II Study of Brentuximab Vedotin to Treat Recurrent or Persistent Germ Cell Tumors

Full Title

A Multicenter Phase II Study of Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors (IUSCC-0568)

Purpose

Patients with germ cell tumors that do not respond well to cisplatin chemotherapy typically receive high-dose chemotherapy. There is no standard treatment, however, for patients whose cancer returns or continues to grow after high-dose chemotherapy. This study is evaluating a novel treatment, brentuximab vedotin, in patients with germ cell tumors whose cancer returned after high-dose chemotherapy.

Brentuximab vedotin is an anticancer drug used to treat lymphoma. It has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer.

Brentuximab vedotin is given intravenously (by vein).

Eligibility

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

  • Patients must have a germ cell tumor that has continued to grow or came back after prior high-dose chemotherapy, or they must not have been a candidate for or have declined high-dose chemotherapy.
  • There is no limit on the number of previous therapies.
  • At least 2 weeks must pass between the completion of prior chemotherapy or radiation therapy and 3 weeks since any major surgery and entry into the study.
  • 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. Darren Feldman at 646-422-4491.

Protocol

16-1293

Phase

II

Investigator

Co-Investigators

Locations