Safety and Efficacy Study Using Rexin-G for Sarcoma

NCT ID: NCT00505713

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-06-30

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.

Conditions

Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Rexin-G

Intervention Type: GENETIC

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

3

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

Group Type: EXPERIMENTAL

Rexin-G

Intervention Type: GENETIC

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.

4

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

Group Type: EXPERIMENTAL

Rexin-G

Intervention Type: GENETIC

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.

5

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

Group Type: EXPERIMENTAL

Rexin-G

Intervention Type: GENETIC

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.

2

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

Group Type: EXPERIMENTAL

Rexin-G

Intervention Type: GENETIC

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.

Interventions

Rexin-G

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

Rexin-G

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

Rexin-G

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

Rexin-G

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

Rexin-G

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.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed recurrent or metastatic sarcoma that is measurable.

2. 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.

3. Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.

4. Hemoglobin > 9 gms%

5. Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.

6. Serum creatinine of less than 1.5 mg%.

7. 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.

8. Accessibility of peripheral or central IV line

9. Age > 10 years

10. 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.

11. The ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. 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.

2. Woman who are pregnant or nursing

3. 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.

4. Patients who are transfusion dependent (more than one transfusion per month)

5. Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epeius Biotechnologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Epeius Biotechnologies Corporation

Principal Investigators

Sant P Chawla, M.D.

Role: PRINCIPAL_INVESTIGATOR

Epeius Clinical Research Unit/Sarcoma Oncology Center

Locations

Epeius Clinical Research Unit

San Marino, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

Countries

United States

Other Identifiers

C07-103

Identifier Type: -

Identifier Source: org_study_id