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Pilot Study of p53 Intralesional Gene Therapy With Chemotherapy in Breast Cancer

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Pilot Study of p53 Intralesional Gene Therapy With Chemotherapy in Breast Cancer


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

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.


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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Margaret von Mehren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111