Clinical Trial: Phase II Study of Intravenous Rexin-G in Osteosarcoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma
Brief 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 Summary:
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.
Sponsor: Epeius Biotechnologies
Current Primary Outcome: Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria [ Time Frame: 12-18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical efficacy as measured by progression-free survival greater than one month and over-all survival of 6 months or longer; clinical toxicity measures [ Time Frame: 12-18 months ]
Original Secondary Outcome: Same as current
Information By: Epeius Biotechnologies
Dates:
Date Received: December 10, 2007
Date Started: December 2007
Date Completion:
Last Updated: June 9, 2011
Last Verified: February 2010
