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Phase I Study of MDX-1401 in Patients with CD30-Positive Refractory/Relapsed Hodgkin's Lymphoma

[Protocol 07-169]


Full Title :
A PHASE I, OPEN-LABEL, DOSE-ESCALATION, MULTIDOSE STUDY OF MDX-1401 ADMINISTERED WEEKLY FOR 4 WEEKS IN PATIENTS WITH CD30-POSITIVE REFRACTORY/RELAPSED HODGKINS LYMPHOMA
Purpose :

The purpose of this phase I study is to find the highest dose of an investigational drug called MDX-1401 that can be given safely to patients with Hodgkin's lymphoma that has stopped responding to or has returned despite other treatments.

MDX-1401 is a monoclonal antibody that targets the CD30 protein, which is found in large numbers on many Hodgkin's lymphoma cells. Laboratory research has shown that MDX-1401 can kill Hodgkin's lymphoma cells or slow or stop cancer cell growth completely.

Eligibility :

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

  • Patients must have a confirmed diagnosis of Hodgkin's lymphoma that expresses the CD30 protein.
  • Patients' disease must have returned or failed to respond to second-line therapy.
  • At least 4 weeks must have passed since completion of chemotherapy or radiation therapy and receipt of the first dose of MDX-1401, and patients must have recovered from any side effects.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • Patients must be age 12 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Steven M. Horwitz at 212-639-3045.

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