NCT00079131

Oblimersen in Treating Patients With Merkel Cell Carcinoma

A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Recurrent Neuroendocrine Carcinoma of the Skin
• Stage I Neuroendocrine Carcinoma of the Skin
• Stage II Neuroendocrine Carcinoma of the Skin
• Stage III Neuroendocrine Carcinoma of the Skin
• Stage IV Neuroendocrine Carcinoma of the Skin

Interventions

Type	Name	Description
BIOLOGICAL	oblimersen sodium	Given IV
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-01-01
• First posted: 2004-03-09
• Last updated: 2013-06-04

Locations

1 site across 1 country: United States