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Phase I/II Evaluation of Safety and Efficacy of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Breast Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase I/II Evaluation of Safety and Efficacy of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Breast Cancer

The 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 for breast cancer.

Inclusion Criteria:

1. Histologically or cytologically confirmed recurrent or metastatic breast cancer that
is refractory to standard chemotherapy and 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

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 > 18 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:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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:

24 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:

  • Breast Cancer
  • Breast Cancer
  • Rexin-G
  • Gene Therapy
  • Breast Neoplasms



Sarcoma Oncology Center Santa Monica, California  90403
Epeius Clinical Research Unit San Marino, California  91108
Bruckner Oncology New York, New York  10003