Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Introgen Therapeutics |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00044993 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Combining chemotherapy with gene therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Biological: Ad5CMV-p53 gene Drug: docetaxel Drug: doxorubicin hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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) |
Study Start Date: | February 2002 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Jill Van Warthood, PhD | Introgen Therapeutics |
Study ID Numbers: | CDR0000256223, INTROGEN-201-010, MDA-ID-00008 |
Study First Received: | September 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00044993 History of Changes |
Health Authority: | United States: Federal Government |
male breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Docetaxel Anti-Bacterial Agents Skin Diseases Breast Neoplasms, Male |
Breast Neoplasms Breast Cancer, Male Doxorubicin Breast Diseases |
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Breast Diseases |