Phase II Study of Intravenous Rexin-G in Osteosarcoma

Completed · Phase 2

Conditions studied: Osteosarcoma

In brief

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.

Key facts

Study ID

NCT00572130

Run by

Epeius Biotechnologies

People needed

22

Starts

2007-12-01

Expected to finish

2011-06-01

Last updated by the study team

2011-06-10

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with recurrent or metastatic osteosarcoma who is considered refractory to known therapies.
• Histologically or cytologically confirmed osteosarcoma that is measurable.
• Adequate hepatic function: Total bilirubin < 2.0 mg/dL (upper limit included); AST/ALT < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. Patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within normal limits.
• Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.
• Hemoglobin > 9 gms%
• Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.
• Serum creatinine of less than 1.5 mg%.
• There must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
• Accessibility of peripheral or central IV line
• Age > 10 years
• Patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to Grade 1 or less toxicity.
• The ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, CIS of cervix from which the patient has been disease-free for 5 years.
• Woman who are pregnant or nursing
• Fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. Male patients must agree to use barrier contraception.
• Patients who are transfusion dependent (more than one transfusion per month)
• Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
• Patient who do not meet the inclusion criteria.

Where it is running

• Epeius Clinical Research Unit/Sarcoma Oncology Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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