Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma.

Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Research Abstract Details 

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Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Abstract Text:

Lee M Krug,Robert T Heelan,Mark G Kris,Ennapadam Venkatraman,F M Sirotnak,

BACKGROUND: Several previous clinical trials have shown that malignant pleural mesothelioma is responsive to antifolates. The dihydrofolate reductase inhibitor, pralatrexate, has a favorable toxicity profile, primarily limited to stomatitis, and has demonstrated activity in patients with non-small cell lung cancer. In mesothelioma cell lines and xenografts, pralatrexate demonstrated significant antitumor activity. METHODS: We conducted this phase II study to determine the response rate of malignant pleural mesothelioma to pralatrexate at a dose of 135 mg/m2 i.v. every 2 weeks. After a protocol amendment, patients were supplemented with vitamin B12 and folic acid at the time of starting therapy. RESULTS: A total of 16 assessable patients were enrolled. No complete or partial responses were observed. Two patients with epithelioid histology had minor responses. Three other patients remained on study with stable disease for 9, 9, and 48 months. The median time to progression was 3 months. The overall median survival time was 7 months (95% confidence interval: 3.2-16.2 months) and the one-year survival was 31% (95% confidence interval: 15%-65%). Three patients (19%) had grade 2 stomatitis, eight (50%) had grade 3, and one (6%) had grade 4. CONCLUSIONS: With this particular dose and schedule, pralatrexate as a single agent had no activity in malignant pleural mesothelioma.

Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Publishing Authors By Initials

LM Krug,RT Heelan,MG Kris,E Venkatraman,FM Sirotnak,

For similar persons: terminally ill research abstracts see: persons: terminally ill research

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Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Journal of thoracic oncology : official publicatio

VOLUME: 2

Page Numbers: 317-20

Journal Abbreviation:

ISSN: 1556-1380

DAY: 3

MONTH: Apr

YEAR: 2007

Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Information

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LANGUAGE: eng

NlmUniqueID: 101274235

Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Keywords Mesh Terms:

KEYWORDS: Terminally Ill

MESH TERMS: pathology

Chemical & Substance for Abstract: Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma. Information

Substance Name: Aminopterin

Registry Number: 54-62-6

Grant and Affiliation Information for Phase II trial of pralatrexate (10-propargyl-10-deazaaminopterin, PDX) in patients with unresectable malignant pleural mesothelioma.

AFFILIATION: Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, Weill Medical College of Cornell University, New York, New York 10021, USA. krugl@mskcc.org

Country: United States

AGENCY: United States NCI

GRANT: CA-05826

ACRONYM: CA

MEDLINETA: J Thorac Oncol

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