Pilot Study of p53 Intralesional Gene Therapy With Chemotherapy in Breast Cancer
Ad5CMV-p53 gene
+ chemotherapy
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: January 1, 1999
Actual date on which the first participant was enrolled.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. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Absolute granulocyte count at least 1,500/mm3 Hemoglobin greater than 8 g/dL Platelet count greater than 100,000/mm3 Bilirubin less than 2 mg/dL PT/PTT within normal range SGOT/SGPT less than 2 times upper limit of normal Creatinine less than 1.8 mg/dL Not pregnant Fertile patients must use effective contraception during and for 3 months after therapy PRIOR CONCURRENT THERAPY: Concurrent cytotoxic chemotherapy allowed, if stable and responding At least 4 weeks since prior chemotherapy, if starting a new regimen 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 Recovered from prior therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location