- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00505271
Safety and Efficacy Study Using Rexin-G for Breast Cancer
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Marino, California, United States, 91108
- Epeius Clinical Research Unit
-
Santa Monica, California, United States, 90403
- Sarcoma Oncology Center
-
-
New York
-
New York, New York, United States, 10003
- Bruckner Oncology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic and metabolic profiles.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify an objective tumor response to Rexin-G
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C07-104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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