A Phase I Study of Brentuximab Vedotin plus Temsirolimus in Relapsed and Refractory Hodgkin Lymphoma

Protocol
13-044
Full Title
A Phase 1 Study of brentuximab Vedotin in Combination with Temsirolimus in Relapsed and Refractory Hodgkin Lymphoma (NCI #9467)
Phase
I
Disease Status
Relapsed/Refractory
Purpose

Brentuximab vedotin is a drug used to treat Hodgkin lymphoma that has returned or continued to grow despite therapy. 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. Temsirolimus is approved for the treatment of advanced kidney cancer, but its use in Hodgkin lymphoma is considered investigational. It works on a protein called mTOR.

While brentuximab vedotin and temsirolimus have different ways of working, laboratory studies suggest that they have more anticancer activity when combined. The purpose of this study is to assess the safety and effectiveness of giving both of these drugs in patients with Hodgkin lymphoma that has returned or continued to grow despite a stem cell transplant or two prior regimens of therapy. Both drugs are 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 Hodgkin lymphoma that has returned or continued to grow despite a stem cell transplant or two prior regimens of therapy.
  • Patients’ cancers must contain the CD30 protein (the target of brentuximab vedotin).
  • At least 3 weeks must have passed since completion of chemotherapy or radiation therapy and entry into the study. For patients whose prior treatment included brentuximab vedotin, therapy must have been completed 6 or more months prior to study entry.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients ages 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alison Moskowitz at 212-639-4839.

Disease(s)
Lymphoma: Hodgkin's Disease
Locations
Related Diseases