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Phase II Study of Intravenous Rexin-G in Osteosarcoma

Primary Purpose

Osteosarcoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rexin-G Dose 1

Rexin-G Dose 2

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring Tumor-targeted gene medicine, Cyclin G1 gene, Osteosarcoma

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Epeius Clinical Research Unit/Sarcoma Oncology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Rexin-G Dose 1

Rexin-G Dose 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00572130

First Posted

December 10, 2007

Last Updated

June 9, 2011

Sponsor

Epeius Biotechnologies

1. Study Identification

Unique Protocol Identification Number

NCT00572130

Brief Title

Phase II Study of Intravenous Rexin-G in Osteosarcoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Epeius Biotechnologies

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteosarcoma

Keywords

Tumor-targeted gene medicine, Cyclin G1 gene, Osteosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rexin-G Dose 1

Arm Type

Experimental

Arm Title

Rexin-G Dose 2

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

Rexin-G Dose 1

Intervention Description

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

Intervention Type

Genetic

Intervention Name(s)

Rexin-G Dose 2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

12-18 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sant P Chawla, M.D.

Organizational Affiliation

Epeius Clinical Research Unit/Sarcoma Oncology Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Epeius Clinical Research Unit/Sarcoma Oncology Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

91108

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.epeiusbiotech.com

Description

Sponsor's Official Website

Learn more about this trial

Phase II Study of Intravenous Rexin-G in Osteosarcoma

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