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Trimodal Lung-Sparing Treatment of Pleural Mesothelioma

Sponsored by Columbia University

Phase Quota
Phase 2

The primary objective of the study is to determine the feasibility (as determined by lack of serious adverse events) and tolerability (as determined by patient's ability to complete the study) of a multimodal lung sparing regimen of surgery, interpleural and intravenous chemotherapy, and local P-32 irradiation for malignant pleural mesothelioma.

Study Start Date: February 2008

Estimated Completion Date: December 2014

Specialties: Pulmonology: Lung/Thoracic Oncology Oncology: Lung/Thoracic Oncology Pharmacy: Chemotherapy/Oncology

Interventions

  • Drug: Doxorubicin and cisplatin (intrapleural) + cisplatin and pemetrexed (systemic)

Inclusion criteria

  • Histologically confirmed malignant mesothelioma, < 20% sarcomatoid type
  • No radiographic or other imaging evidence of Stage IV (cardiac, mediastinal, peritoneal, other distant) disease
  • Ineligible for other high priority national or institutional study
  • Age >18 years [to physiologic 75 years]
  • Life expectancy > 3 months
  • Performance status, PS 0-2 [Karnofsky Performance Status, KPS=70-100 %]
  • Prior therapy allowed (one prior systemic regimen) meeting the following parameters
  • No prior chest radiation therapy within 6 weeks of treatment
  • No prior chemotherapy regimens within four weeks of treatment
  • Non pregnant, non-lactating. (serum HCG test will be performed in patients in whom there is a possibility of pregnancy.)
  • Required initial laboratory data/clinical parameters (see also Sec. 8.0) White cell count: >3000/ul. Platelet count: >100,000/ul. Creatinine clearance: >= 45 ml/min Bilirubin: < 2 x ULN SGOT or SGPT: < 2 x ULN
  • Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
  • No other coexistent malignancy. However, curatively treated or fully controlled solid tumors (other than mesothelioma) may be eligible if in the judgement of the PI, the benefit of treatment outweighs the risk
  • No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection, congestive heart failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled hypertension). HIV status or other severe illnesses will be assessed using medical records

Exclusion criteria

  • None

Study Locations And Contact Information

  • Columbia University Medical Center, New York New York
    Contact: Danielle Banks 212-305-3846 db2707@columbia.edu

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