Status:
COMPLETED
Brentuximab Vedotin (SGN-35) as Salvage Treatment for CD30-positive Germ Cell Tumors
Lead Sponsor:
Fondazione Michelangelo
Collaborating Sponsors:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Millennium Pharmaceuticals, Inc.
Conditions:
Germ Cell Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ cell tumors.
Detailed Description
Complete responses with third-line or later salvage chemotherapy (CT) for germ cell tumors (GCT) range 0% to 10% and are usually short-lived and nearly all patients (pts) progressing after multiple co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01851200
Start Date
May 1 2013
End Date
September 1 2017
Last Update
February 7 2018
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Mi, Italy, 20133