Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer

NCT00004038 | Completed Phase 1

• 4 other identifiers: NCI-2012-02273FCCC-97009NCI-T97-0042CDR0000066480
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer. 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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Biological: Ad5CMV-p53 gene; Drug: chemotherapy

Interventions

Ad5CMV-p53 gene BIOLOGICAL

Arm I

chemotherapy DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

advexin; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Margaret von Mehren, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: May 20, 2004
• Study Start: January 1, 1999
• Primary Completion: May 1, 2001
• Last Updated: February 7, 2013

Record last verified: 2001-06

Locations

US (1)