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A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer (NCT00003588)

Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian cancer that has not responded to previous treatment. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer cells more sensitive to treatment.
  • Biological: Ad5CMV-p53 gene
    • Procedure: laparoscopic surgery
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers

      I. Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer.

      II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

      III. Document the observed anti-tumor activity of this regimen in these patients.

      IV. Evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this regimen in these patients.

      OUTLINE: This is a dose escalation study.

      Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.

      1 locations

      United States (1)
      • University of Texas - MD Anderson Cancer Center
        Not specified
        Houston, Texas, United States, 77030
      31 August, 1998
      06 February, 2013
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