PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
Completed · Phase 2
Conditions studied: Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma
In brief
This phase II trial is studying how well PXD101 works as second-line therapy in treating patients with malignant mesothelioma of the chest that cannot be removed by surgery. PXD101 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Key facts
- Study ID
- NCT00365053
- Run by
- National Cancer Institute (NCI)
- People needed
- 13
- Starts
- 2006-06-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2018-06-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes:
- Epithelial
- Sarcomatoid
- Mixed
- Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma
- Prior intrapleural cytotoxic agents (including bleomycin) not considered systemic chemotherapy
- Patients who are not candidates for combination chemotherapy are eligible even if they have not received prior chemotherapy
- Unresectable disease
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- The sole site of measurable disease must not be located within the radiotherapy port
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 3 months
- WBC >= 3,000/mm\^3
- Absolute neutrophil count >= 1,500/mm\^3
- Platelet count >= 100,000/mm\^3
- Bilirubin normal
- AST/ALT =< 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance >= 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception for 1 week before, during, and for >= 2 weeks after completion of study treatment
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
- No symptomatic congestive heart failure
- No congestive heart failure related to primary cardiac disease
Where it is running
- City of Hope — Duarte, California, United States
Full record on ClinicalTrials.gov
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