Clinical trial · Interventional
Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
Pilot Study of p53 Intralesional Gene Therapy With Chemotherapy in Breast Cancer
NCT00004038CI-TRIAL-00009362completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ad5CMV-p53 gene | Biological | — | UNRESOLVED |
| chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Biological: Ad5CMV-p53 gene
- Drug: chemotherapy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.