NCT00668382

Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection

Phase I Study To Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection Of Alpha-Gal Glycosphingolipids In Patients With Advanced Or Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced, refractory solid tumors who have failed standard therapies or are not eligible for standard treatment.

Detailed description

Intratumoral injection of alpha gal glycolipid in experimental knockout mouse model systems incorporates into tumor cell membranes and presents these xeno-transplantation epitopes to antigen presenting cells with that particular tumor's tumor associated antigens (TAA). Thus this maneuver converts any individual tumor into an in situ tumor vaccine without the need to isolate, purify or supply TAA exogenously. The effects in these model systems demonstrate both the upregulation of cytotoxic T cells which react against the particular tumor's TAA, as well as resolution of injected primary tumor and eradication and prevention of metastatic disease at distant sites. This current study was undertaken to investigate the safety and feasibility of such an approach in humans. The major toxicity concerns are acute allergic or complement activation reactions or development of autoimmunity. The primary treatment is a single intratumoral injection of alpha gal glycolipid. The study design is a standard dose escalation design and the primary endpoint is Dose limiting toxicity at one month after injection (grade 3 or 4. Subjects are followed until death utilizing standard clinical imaging and evaluation to judge overall tumor response.

Conditions

• Neoplasm Metastases

Interventions

Type	Name	Description
BIOLOGICAL	Alpha-Gal Glycosphingolipid	Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2008-04-29
• Last updated: 2013-05-15
• Results posted: 2012-11-26

Locations

1 site across 1 country: United States