Phase II Study of Intravenous Rexin-G in Osteosarcoma

NCT00572130 | Completed Phase 2 DMC

• 1 other identifier: C07-110
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteosarcoma

Keywords

Tumor-targeted gene medicine; Cyclin G1 gene; Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria

  12-18 months

Secondary Outcomes (1)

• Clinical efficacy as measured by progression-free survival greater than one month and over-all survival of 6 months or longer; clinical toxicity measures

  12-18 months

Study Arms (2)

Rexin-G Dose 1

EXPERIMENTAL

Genetic: Rexin-G Dose 1

Rexin-G Dose 2

EXPERIMENTAL

Genetic: Rexin-G Dose 2

Interventions

Rexin-G Dose 1 GENETIC

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

Rexin-G Dose 1

Rexin-G Dose 2 GENETIC

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

Rexin-G Dose 2

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Epeius Biotechnologies: lead

Study Sites (1)

Epeius Clinical Research Unit/Sarcoma Oncology Center

Los Angeles, California, 91108, United States

Location

Related Links

• Sponsor's Official Website

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Sant P Chawla, M.D.

  Epeius Clinical Research Unit/Sarcoma Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 10, 2011

Record last verified: 2010-02

Locations

US (1)