Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Not Recruiting

Trial ID: NCT01026233

Age - 18 Years-N/A Condition - Lymphomas: Non-Hodgkin, Cutaneous Lymphoma Gender - All Accepting Healthy Volunteers - No

Purpose

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Official Title

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

Eligibility


Inclusion Criteria:

   - Relapsed or refractory CD30-positive malignancy

   - Adequate organ function

   - ECOG performance status <2

Exclusion Criteria:

   - Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)

   - Current diagnosis of primary cutaneous ALCL

   - Acute or chronic graft-versus-host disease

   - Prior hematopoietic stem cell transplant within specified timeframe

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Intervention(s):

drug: Brentuximab vedotin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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