Safety and Efficacy Study Using Rexin-G for Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00505271
- Run by
- Epeius Biotechnologies
- People needed
- 20
- Starts
- 2007-07-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2011-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and 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 > 18 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.
You may not qualify if…
- 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.
Where it is running
- Epeius Clinical Research Unit — San Marino, California, United States
- Sarcoma Oncology Center — Santa Monica, California, United States
- Bruckner Oncology — New York, New York, United States
Full record on ClinicalTrials.gov
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