NCT00572130

Phase II Study of Intravenous Rexin-G in Osteosarcoma

A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Epeius Biotechnologies · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

Rexin-G is a tumor-targeted gene medicine that is designed to seek out and destroy both primary tumors and metastatic cancers without the side effects of standard chemotherapy. The objectives of the study are: (1) to evaluate the clinical effectiveness of intravenous injections of Rexin-G, a tumor-targeted gene vector, in controlling tumor growth and prolonging life, and (2) to evaluate its over-all safety.

Detailed description

The adaptive trial design of this advanced Phase II study incorporates (i) a dosing schedule based on the patient's estimated tumor burden and not on standard dosing per kilogram body weight or body surface area, and (2) a tumor response evaluation process that is unique to the manner in which osteosarcoma responds favorably to therapy, i.e., with necrosis and increasing calcification in metastatic tumors and decreased glucose utilization using PET-CT imaging studies. Twenty to thirty patients will receive Rexin-G at either Dose Level 1 or 2. Patients will be assigned a dose level based on the estimated tumor burden as measured by PET-CT imaging studies. Estimated tumor burden is measured by multiplying the sum of the longest diameters of target lesions in cm by 10e9 cancer cells. If the tumor burden is less than 10 billion cells, the patient will be assigned to Dose Level 1, if the tumor burden is greater than 10 billion cells, the patient will be assigned to Dose Level 2. \*Treatment Cycle Dose Level Vector Dose/Day Max.Volume/Dose Two times a week 1 1.0 x 10e11 cfu 200 ml Three times a week 2 1.0 x 10e11 cfu 200 ml \* Each treatment cycle will be six weeks (four weeks of treatment and two weeks of rest). Patients who have resolution of toxicity to \< grade I may have repeat cycles. After one or more treatment cycles, the principal investigator may recommend surgical debulking or complete surgical removal. If residual disease is present either by histopathological examination or by PET-CT scan, repeat treatment cycles may be given 3-4 weeks after surgery, if the surgical incision has healed, and if the patient has \< grade I toxicity.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
GENETIC	Rexin-G Dose 1	Rexin-G i.v., 1 x 10e11 cfu, two times a week x 4 weeks, rest 2 weeks May be repeated if grade 1 or less toxicity
GENETIC	Rexin-G Dose 2	Rexin-G i.v., 1 x 10e11 cfu, three times a week x 4 weeks; rest 2 weeks May repeated if grade 1 or less toxicity

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-07-01
• Completion: 2011-06-01
• First posted: 2007-12-12
• Last updated: 2011-06-10

Locations

1 site across 1 country: United States