Phase II Study of Intravenous Rexin-G in Osteosarcoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma|
- Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Experimental: Rexin-G Dose 1||
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
|Experimental: Rexin-G Dose 2||
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
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.
|United States, California|
|Epeius Clinical Research Unit/Sarcoma Oncology Center|
|Los Angeles, California, United States, 91108|
|Principal Investigator:||Sant P Chawla, M.D.||Epeius Clinical Research Unit/Sarcoma Oncology Center|