Germ Cell Cancer Clinical Trial
Official title:
Brentuximab Vedotin (SGN-35) as Salvage Therapy for Males With Advanced and Platinum-resistant Germ-cell Tumors. An Open Label, Single Group, Phase 2 Trial.
Verified date | April 2016 |
Source | Fondazione Michelangelo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ cell tumors.
Status | Completed |
Enrollment | 9 |
Est. completion date | September 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | Mi |
Lead Sponsor | Collaborator |
---|---|
Fondazione Michelangelo | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Millennium Pharmaceuticals, Inc. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Metabolic response to Brentuximab Vedotin measured by means of a Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scan. | Six weeks after the first administration of the study drug. | ||
Primary | The number of objective responses (partial and complete responses) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 integrated with response of serum tumor markers. | Six weeks after the first administration of the study drug. | ||
Secondary | Progression-Free Survival | 3 months after the initiation of study treatment | ||
Secondary | Overall Survival | Six months after the initiation of study treatment | ||
Secondary | Incidence of adverse events related to the study drug | Six weeks after the initiation of the study drug and every 6 weeks thereafter up to 16 weeks. |
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