Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | 18 and over | Pharmaceutical / Industry | INTROGEN-201-010 MDA-ID-00008, NCT00044993 |
Objectives
- Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.
Entry Criteria
Disease Characteristics:
- Histologically confirmed breast cancer
- Stage IIIA, IIIB (excluding inflammatory breast carcinoma), or IIIC OR
- Localized stage IV
- Measurable disease
- No metastases
- Hormone receptor status:
- Not specified
Prior/Concurrent Therapy:
Biologic therapy
- No prior gene therapy using adenoviral vectors or p53 gene product
Chemotherapy
- No prior chemotherapy for breast cancer
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age
- 18 and over
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Adequate bone marrow function
Hepatic
- Adequate liver function
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Adequate kidney function
Cardiovascular
- Normal cardiac function by MUGA and/or echocardiogram
Other
- No psychological, familial, sociological, or geographical conditions that would preclude study
- Not pregnant or nursing
- Fertile patients must use effective barrier method of contraception
Expected Enrollment
A maximum of 60 patients will be accrued for this study.
Outline
Patients receive p53 gene by intralesional injection on days 1 and 2. Patients also receive doxorubicin IV over 15 minutes followed 1 hour later by docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses. After completion of chemotherapy, patients with a reasonable response undergo surgical resection.
Trial Lead Organizations
Introgen Therapeutics, Incorporated
 | | | |
| Jill Van Warthood, PhD, Protocol chair | |
| |
| |||
| Registry Information | ||
| ||
| Official Title | Phase II, Single Arm, Single Institution Clinical Trial of Docetaxel and Doxorubicin in Combination with Local Administration of INGN 201 (Ad5CMV-p53) in Locally Advanced Breast Cancer (LABC) | |
| ||
| Trial Start Date | 2002-02-11 | |
| ||
| Registered in ClinicalTrials.gov | NCT00044993 | |
| ||
| Date Submitted to PDQ | 2002-06-19 | |
| ||
| Information Last Verified | 2004-07-16 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Back to Top
