Safety and Efficacy Study Using Rexin-G for Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Epeius Biotechnologies
ClinicalTrials.gov Identifier:
NCT00505271
First received: July 19, 2007
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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 recurrent or metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Genetic: Rexin-G
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Epeius Biotechnologies:

Primary Outcome Measures:
  • Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic and metabolic profiles. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To identify an objective tumor response to Rexin-G [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Escalating doses of Rexin-G will be given two or three times a week for four weeks, with a 2 week rest period
Genetic: Rexin-G

Three patients will receive Rexin-G at Dose Level I. If 1 of 3 patients at Dose Level I develops a grade 3 or 4 adverse event (CTCAE Version 3.0) which appears to be related or possibly related to Rexin-G, then 3 additional patients will be enrolled at the same dose level. If at least 2 of the first 3, or 3 of 6 patients at Dose Level I develop a grade 3 to 4 adverse event which appears to be related or possibly related to Rexin-G, accrual into the study will be held.

At any dose level, up to six patients may be enrolled if there is evidence of biological activity in the first three patients. Dose escalation may stop if there is impressive evidence of biological activity. An amendment would be submitted to allow further expansion of dose level based on impressive biological activity.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 > 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 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.
  6. Patient who do not meet the inclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505271

Locations
United States, California
Epeius Clinical Research Unit
San Marino, California, United States, 91108
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, New York
Bruckner Oncology
New York, New York, United States, 10003
Sponsors and Collaborators
Epeius Biotechnologies
Investigators
Principal Investigator: Sant P Chawla, M.D. Epeius Clinical Research Unit/Sarcoma Oncology Center
Principal Investigator: Howard W Bruckner, M.D. Bruckner Oncology
  More Information

No publications provided

Responsible Party: Erlinda M. Gordon, M.D., Epeius Biotechnologies Corporation
ClinicalTrials.gov Identifier: NCT00505271     History of Changes
Other Study ID Numbers: C07-104
Study First Received: July 19, 2007
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Epeius Biotechnologies:
Breast Cancer
Rexin-G
Gene Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014