NCT00394693

Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma

Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Transgene · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL. Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
GENETIC	Adenovirus Interferon gamma	intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2006-11-01
• Last updated: 2014-07-16

Locations

6 sites across 3 countries: United States, France, Switzerland