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Home > "G" Clinical Trials Conditions > Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer  Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
For Condition: recurrent breast cancer,stage 1 breast cancer,stage 4 breast cancer,stage 2 breast cancer,stage 3A breast cancer,stage 3B breast cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Combining chemotherapy with gene therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer.
Details: OBJECTIVES: I. Determine the effect of adenovirus p53 (Ad-p53) on chemotherapy-induced apoptosis in lesions in patients with breast cancer. II. Determine p53 protein expression following intralesional injections of Ad-p53 by immunohistochemistry and reverse transcriptase polymerase chain reaction in this patient population. III. Determine the time course and magnitude of the development of a humoral antibody response to the adenoviral vector in this patient population. IV. Determine the ability of transfected p53 to upregulate downstream signals important in G1 arrest by assaying for WAF1 mRNA and apoptosis in this patient population. V. Determine the toxicities and side effects of intralesional injections of Ad-p53 given in combination with standard chemotherapy in patients with cutaneous and subcutaneous metastatic breast cancer amenable to injections and biopsies. VI. Determine if there is an increase in apoptosis induced by Ad-53 compared to baseline in this patient population. PROTOCOL OUTLINE: Patients undergo biopsy of one of their skin nodules prior to any treatment. Patients receive the Ad-p53 gene therapy in one nodule and injection of a second nodule with Dulbecco's phosphate buffered saline. The next day, patients begin chemotherapy, which may be given weekly and continues every 21-28 days for up to 6 courses. On day 3, patients return for biopsy of injected nodules. Biopsies are only performed during the first course. Patients may receive further injections of the Ad-p53 gene with subsequent courses of chemotherapy, for up to six courses. Patients are followed monthly for 4 months. PROJECTED ACCRUAL: Approximately 12-20 patients will be accrued for this study within 12-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed epithelial breast cancer - At least 3 cutaneous or subcutaneous lesions required - Measurable disease that includes, but is not limited to, cutaneous or subcutaneous metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Concurrent cytotoxic chemotherapy allowed, if stable and responding; At least 4 weeks since prior chemotherapy, if starting a new regimen - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since radiotherapy; Prior adjuvant radiotherapy to the chest wall allowed; At least 6 months since radiotherapy to lesions that are to be injected - Surgery: Not specified - Other: Recovered from prior therapy --Patient Characteristics-- - Age: Over 18 - Menopausal status: Not specified - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Hemoglobin greater than 8 g/dL; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 2 mg/dL; PT/PTT within normal range; SGOT/SGPT less than 2 times upper limit of normal - Renal: Creatinine less than 1.8 mg/dL - Other: Not pregnant; Fertile patients must use effective contraception during and for 3 months after therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MargaretMehren, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000066480; FCCC-97009,NCI-T97-0042
Study Start Date: January 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004038
Other Recurrent Breast Cancer Studies:
1. Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
2. Suppression of Ovarian Function and Either Tamoxifen or Exemestane With or Without Chemotherapy in Treating Premenopausal Women With Resected Breast Cancer
3. Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
4. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
5. Medroxyprogesterone in Treating Women With Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
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