Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Status: Recruiting
Phase: Phase 2
Diagnosis: Multiple Myeloma, Leukemia/MDS
NCT ID: NCT01461538
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-449
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Dana-Farber Cancer Institute:
Deborah Doss, 617-632-5672,
ddoss@partners.org
Eligibility Criteria
Inclusion Criteria:
- Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
- Have failed, refused, or have been deemed ineligible for standard therapy
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a
Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion Criteria:
- Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
- History of another primary invasive malignancy that has not been definitively treated
or in remission for at least 3 years
- Evidence of active cerebral/meningeal disease