Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring recurrent malignant mesothelioma, stage IA malignant mesothelioma, stage IB malignant mesothelioma, stage II malignant mesothelioma, stage III malignant mesothelioma, stage IV malignant mesothelioma Read More

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically confirmed malignant pleural mesothelioma

• Meets 1 of the following criteria for first-line or second-line chemotherapy:

  • Patients in the first-line setting must be unsuitable for, cannot access locally, or refuse combination chemotherapy

  • Patients in the second-line setting must be unsuitable for, cannot access locally, or refuse cytotoxic chemotherapy after failure of a first-line regimen

    • Second-line patients may not have received more than 1 prior line of antineoplastic treatment for this cancer

• Pleural effusions should be drained before treatment whenever possible

  • Talc or tetracycline pleurodesis may be used per standard practice for uncontrollable pleural effusions (recurrent despite regular drainage)

Exclusion criteria:

• Symptomatic or known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-2
• Hemoglobin ≥ 10 g/dL
• Neutrophil count ≥ 1,500 mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine clearance ≥ 30 mL/min
• AST and ALT < 3 times upper limit of normal
• Fertile patients must use effective contraception during study therapy

Exclusion criteria:

• Pregnant or breastfeeding
• History of prior malignant tumor within the past 3 years except for nonmelanoma skin tumor or carcinoma in situ of the cervix
• Patients suitably fit to receive a platinum doublet based chemotherapy (first-line only)

• Uncontrolled or severe cardiovascular disease including any of the following:

  • Myocardial infarction within the past 6 months
  • New York Heart Association class III or IV heart failure
  • Uncontrolled angina
  • Clinically significant pericardial disease
  • Cardiac amyloidosis
• Neuropathy ≥ grade 2 OR grade 1 with pain
• Serious medical (e.g., uncontrolled diabetes, hepatic disease, or infection) or psychiatric illness that would interfere with study participation
• Patients with known HIV or hepatitis B or C infection

PRIOR CONCURRENT THERAPY:

• No prior bortezomib
• No prior extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
• No preplanned surgery or procedures that would interfere with the study

• More than 4 weeks since enrollment in another therapeutic clinical trial (i.e., received an experimental drug or used an experimental medical device)

  • Concurrent participation in non-treatment studies is allowed provided they do not interfere with participation in this study

• No concurrent experimental or antineoplastic agent other than bortezomib

  • Medications that may have antineoplastic activity, but are taken for other reasons than specific antineoplastic effect (e.g., megestrol [Megace®], cyclo-oxygenase-2 [COX-2] inhibitors, or bisphosphonates) are allowed