A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every >= 3 Week Brentuximab Vedotin
I. To estimate the response rate following weekly brentuximab vedotin (1.2mg/kg 3 of 4 weeks
for up to four 28-day cycles) in patients with lack of response (< partial response [PR]) or
progression following brentuximab vedotin and demonstrating persistent expression of CD30.
I. To monitor clinical outcome following the study treatment regimen. II. To estimate the
frequency of CD30 loss in patients following resistance to brentuximab vedotin.
III. To describe the pattern of CD30 expression (membranous, cytoplasmic, Golgi) in
comparison to the pre-brentuximab vedotin expression.
IV. To semi-quantitatively estimate and compare the surface density of CD30 pre and post
brentuximab vedotin as measured by flow cytometry.
V. To correlate response with CD30 density as measured by flow cytometry. VI. To evaluate
the tolerability of the weekly regimen in patients previously exposed to brentuximab
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and
15. Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months
for 1 year, and then every 6 months for 4 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate as measured by the Cheson 2007 criteria
No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is >= 20%.
Up to 5 weeks after completion of study treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|