Clinical Trial: Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter Phase II Study of Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors

Brief Summary: This is a Phase II study to evaluate the activity of brentuximab vedotin in relapsed/refractory non-seminomatous germ cell tumors (NSGCT).

Detailed Summary:

Primary Objective To determine the anti-tumor efficacy of brentuximab vedotin in relapsed/ refractory NSGCT.

Secondary Objectives

  1. To determine the progression free survival in patients with relapsed/ refractory NSGCT treated with brentuximab vedotin.
  2. To determine the overall survival of patients with relapsed/ refractory NSGCT treated with brentuximab vedotin.
  3. To determine the safety and tolerability of brentuximab vedotin in this patient population.

Eligible 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
Sponsor: Costantine Albany

Current Primary Outcome: Objective response (proportion of patients who achieve either a partial or complete response) [ Time Frame: Before cycle 3 (i.e., at +43 days) ]

Measured by CT and MRI for target lesions, serum markers AFP or beta-hCG, in patients whose only evidence of disease is serum tumor markers


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival [ Time Frame: From date of initiation of therapy until the time of disease progression or death (which ever comes first) up to 2 years ]
  • Toxicity [ Time Frame: Every cycle (i.e. at +22 days, +43 days, etc.) ]
    Toxicities will be assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade of each toxicity will be recorded for each patient over the course of treatment (all cycles).


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: February 12, 2016
Date Started: March 9, 2016
Date Completion: December 31, 2018
Last Updated: February 8, 2017
Last Verified: February 2017