Brentuximab Vedotin (SGN-35) as Salvage Treatment for CD30-positive Germ Cell Tumors

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ cell tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Michelangelo
• Collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin

Criteria

Inclusion Criteria:

• Age of at least 18 years.

• Confirmation of germ cell tumor histology based on pathologic review at the study site.

• Presence of a CD30 positive embryonal carcinoma component.

• Unequivocal progression of measurable disease.

• A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease EXCEPT for primary mediastinal germ cell tumors where failure of first-line chemotherapy only is accepted.

• Prior high dose chemotherapy with hematopoietic stem cell rescue is allowed.

Exclusion Criteria:

• Failure to meet any of the above inclusion criteria.

• Patients with late-relapse (defined as relapse occurring after at least 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable (and for whom initial surgical extirpation is recommended) are ineligible. Patients with unresectable late disease relapse are eligible.