Trimodal Lung-Sparing Treatment of Pleural Mesothelioma
Condition: Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Doxorubicin; Cisplatin; Pemetrexed; Radiotherapy
Intervention description: A medication used in cancer chemotherapy, derived by chemical semisynthesis from a bacterial species.; Platinum-based antineoplastic; Folate Analog Metabolic Inhibitor; Standard procedure given 3 weeks after last dose of chemotherapy
Intervention MeSH terms: Doxorubicin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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:

          -  If any of the inclusion criteria was not met.