NCT00505713

Safety and Efficacy Study Using Rexin-G for Sarcoma

Evaluation of Safety and Efficacy of Rexin-G as Intervention for Recurrent or Metastatic Sarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Epeius Biotechnologies · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

Rexin-G is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug concentration within tumors. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

Detailed description

The Phase I/II clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

Conditions

• Sarcoma

Interventions

Type	Name	Description
GENETIC	Rexin-G	Dosing Schedule: 1 x 10e11 cfu two times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity
GENETIC	Rexin-G	Dosing Schedule: 1 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
GENETIC	Rexin-G	Dosing Schedule: 3 x 10e11 cfu i.w. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
GENETIC	Rexin-G	Dosing Schedule: 4 x 10e 11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
GENETIC	Rexin-G	Dosing Schedule: 2 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-07-01
• Completion: 2011-06-01
• First posted: 2007-07-23
• Last updated: 2011-06-10

Locations

2 sites across 1 country: United States