Clinical Trials Directory

Trials / Terminated

TerminatedNCT02689219

Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Nabil Adra · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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 1 of each cycle and with CT scans after cycle 2, 4, and every 4 cycles thereafter while receiving treatment.

Conditions

Interventions

TypeNameDescription
DRUGBrentuximab VedotinBoth cohorts will be treated similarly and in parallel but analyzed separately.

Timeline

Start date
2016-03-09
Primary completion
2018-11-13
Completion
2019-01-23
First posted
2016-02-23
Last updated
2019-12-10
Results posted
2019-11-26

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02689219. Inclusion in this directory is not an endorsement.