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Trial Summary

Protocol No.IUSCC-0568
StatusOPEN TO ACCRUAL
Principal InvestigatorAlbany, Costantine
ScopeNational
PhasePhase II
Age GroupAdult
TitlePhase II Study of Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors
DescriptionEligible patients will be divided into two cohorts, those who are CD30 positive and those who are CD30 negative/unknown. Both groups will be treated similarly and in parallel but analyzed separately. CD30 status may be unknown in the unlikely case of tumor-marker-only relapse or when a fresh tumor biopsy is not feasible, and archival tumor tissue is not obtainable despite efforts to do so. These patients will be included in the CD30 negative cohort for analysis purposes, since statistically NSGCT are more likely to be CD30 negative. The number of such patients with unknown CD30 status should not exceed 5 patients.

Eligible patients will be treated with brentuximab vedotin at 1.8 mg/kg IV every 3 weeks (maximum dose of 180 mg) indefinitely until disease progression, unacceptable toxicity, or study closure.Eligible patients with grade 2 peripheral neuropathy at enrollment will be treated with brentuximab vedotin at 1.2 mg/kg IV every 3 weeks (maximum dose of 180 mg) indefinitely until disease progression, unacceptable toxicity, or study closure. Response to treatment will be assessed clinically with history, physical exam and tumor markers measurement (BHCG and AFP) on day 1 of each cycle and with CT scans after cycle 2, 4, and every 4 cycles thereafter while receiving treatment.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have progressed after prior high dose chemotherapy (HDCT) treatment, been deemed not to be a candidate for high dose chemotherapy or refused high-dose chemotherapy, and be considered incurable by other standard therapies including further chemotherapy or surgery.
  • Patients with histologically or serologically confirmed relapsed/refractory non-seminoma germ cell tumor, (i.e., embryonal carcinoma, choriocarcinoma, or yolk sac tumors) including female GCT and primary mediastinal NSGCT.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesMediastinal Tumors
Ovarian Cancer
Testis Cancer
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Intermountain Healthcare
  • Intermountain Healthcare (site)
Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center (site)
University of Southern California
  • University of Southern California (site)
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu