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

Phase 1/Phase 2
10 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria:

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

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

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

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.

6. Patient who do not meet the inclusion criteria.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Sant P Chawla, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Epeius Clinical Research Unit/Sarcoma Oncology Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

June 2011

Related Keywords:

  • Sarcoma
  • Sarcoma
  • Rexin-G
  • Gene Therapy
  • Sarcoma



Sarcoma Oncology Center Santa Monica, California  90403
Epeius Clinical Research Unit San Marino, California  91108