Back to results

Safety and Efficacy Study Using Rexin-G for Sarcoma

Primary Purpose

Sarcoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rexin-G

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Sarcoma, Rexin-G, Gene Therapy

Eligibility Criteria

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

Inclusion Criteria:

Histologically or cytologically confirmed recurrent or metastatic sarcoma 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 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Arm Description

Dose Level 1 of escalating doses of Rexin-G i.v.

Dose Level 3 of escalating doses of Rexin-G i.v.

Dose Level 4 of escalating doses of Rexin-G i.v.

Dose Level 5 of escalating doses of Rexin-G i.v.

Dose Level 2 of escalating doses of Rexin-G i.v.

Outcomes

Primary Outcome Measures

Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles

Secondary Outcome Measures

To identify an objective tumor response to Rexin-G

Full Information

NCT ID

NCT00505713

First Posted

July 19, 2007

Last Updated

June 9, 2011

Sponsor

Epeius Biotechnologies

1. Study Identification

Unique Protocol Identification Number

NCT00505713

Brief Title

Safety and Efficacy Study Using Rexin-G for Sarcoma

Official Title

Evaluation of Safety and Efficacy of Rexin-G as Intervention for Recurrent or Metastatic Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

July 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 (pathotropic or disease-seeking) nanoparticle that when injected intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug concentration within tumors. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

Detailed Description

The Phase I/II clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

6. Conditions and Keywords

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

Sarcoma

Keywords

Sarcoma, Rexin-G, Gene Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Dose Level 1 of escalating doses of Rexin-G i.v.

Arm Title

Arm Type

Experimental

Arm Description

Dose Level 3 of escalating doses of Rexin-G i.v.

Arm Title

Arm Type

Experimental

Arm Description

Dose Level 4 of escalating doses of Rexin-G i.v.

Arm Title

Arm Type

Experimental

Arm Description

Dose Level 5 of escalating doses of Rexin-G i.v.

Arm Title

Arm Type

Experimental

Arm Description

Dose Level 2 of escalating doses of Rexin-G i.v.

Intervention Type

Genetic

Intervention Name(s)

Rexin-G

Intervention Description

Dosing Schedule: 1 x 10e11 cfu two times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity

Intervention Type

Genetic

Intervention Name(s)

Rexin-G

Intervention Description

Dosing Schedule: 1 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Intervention Type

Genetic

Intervention Name(s)

Rexin-G

Intervention Description

Dosing Schedule: 3 x 10e11 cfu i.w. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Intervention Type

Genetic

Intervention Name(s)

Rexin-G

Intervention Description

Dosing Schedule: 4 x 10e 11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Intervention Type

Genetic

Intervention Name(s)

Rexin-G

Intervention Description

Dosing Schedule: 2 x 10e11 cfu i.v. three times a week for 4 weeks followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Primary Outcome Measure Information:

Title

Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles

Time Frame

12 months

Secondary Outcome Measure Information:

Title

To identify an objective tumor response to Rexin-G

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed recurrent or metastatic sarcoma 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

City

San Marino

State/Province

California

ZIP/Postal Code

91108

Country

United States

Facility Name

Sarcoma Oncology Center

City

Santa Monica

State/Province

California

ZIP/Postal Code

90403

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study Using Rexin-G for Sarcoma

We'll reach out to this number within 24 hrs