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Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog (L-NDDP) Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma (NCT00004033)

National Cancer Institute (NCI)
RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available
  • Drug: liposomal NDDP
    • Procedure: therapeutic thoracoscopy
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the antitumor efficacy of a liposomal-cisplatin analogue (L-NDDP) administered into the pleural space in patients with malignant pleural mesothelioma. II. Determine the time to progression and overall survival in this patient population. III. Evaluate the quantitative and qualitative toxicity of intrapleural L-NDDP.

      OUTLINE: All patients undergo a thoracoscopy under general anesthesia. The thoracoscope is removed and any collected fluid is drained from the chest cavity. The first treatment with liposomal-cisplatin analogue (L-NDDP) is administered at this time into the intrapleural space over a 10 minute period. Subsequent 10 minute intrapleural infusions of L-NDDP through a percutaneous catheter are administered every 3 weeks. Treatment continues unless unacceptable toxic effects or disease progression occurs. Antitumor activity is assessed 2 months after the second course of therapy, and every 2 months thereafter.

      PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2.5 years.

      2 locations

      United States (2)
      • NYU School of Medicine's Kaplan Comprehensive Cancer Center
        Not specified
        New York, New York, United States, 10016
      • University of Texas - MD Anderson Cancer Center
        Not specified
        Houston, Texas, United States, 77030-4009
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 August, 1998
      Updated:
      24 March, 2011
      Participants:
      30
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