Recurrent Neuroendocrine Carcinoma of the Skin Clinical Trial
Official title:
A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma
This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).
PRIMARY OBJECTIVES:
I. Determine the overall response rate in patients with Merkel cell carcinoma treated with
oblimersen.
SECONDARY OBJECTIVES:
I. Determine the time to progression in patients treated with this drug. II. Determine the
response duration in patients treated with this drug. III. Determine the safety and
tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of
this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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