Abstract | BACKGROUND: METHODS:
Chemotherapy-naive patients with stage III or IV, unresectable, epithelial or biphasic MPM and normal organ functions were eligible. Pemetrexed (500 mg/m(2) on day 1) and cisplatin (75 mg/m(2) on day 1) were administered every 3 weeks for up to 6 cycles with escalating doses of SS1P administered intravenously on days 1, 3, and 5 during cycles 1 and 2. Tumor response was evaluated every 6 weeks. RESULTS: Twenty-four patients received SS1P at 4 dose levels from 25 to 55 mcg/kg. Grade 3 fatigue was dose-limiting in 1 patient at 55 mcg/kg. The MTD of SS1P was established as 45 mcg/kg. Other grade 3 toxicities associated with SS1P included hypoalbuminemia (21%), back pain (13%), and hypotension (8%). Of 20 evaluable patients, 12 (60%) had a partial response, 3 had stable disease, and 5 had progressive disease. Of 13 patients who received the MTD, 10 (77%) had a partial response, 1 had stable disease, and 2 had progressive disease. Objective radiologic responses were associated with significant decreases in serum mesothelin (P=.0030), megakaryocyte potentiating factor (P=.0005), and cancer antigen 125 (P < .0001). CONCLUSIONS:
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Authors | Raffit Hassan, Elad Sharon, Anish Thomas, Jingli Zhang, Alexander Ling, Markku Miettinen, Robert J Kreitman, Seth M Steinberg, Kevin Hollevoet, Ira Pastan |
Journal | Cancer
(Cancer)
Vol. 120
Issue 21
Pg. 3311-9
(Nov 01 2014)
ISSN: 1097-0142 [Electronic] United States |
PMID | 24989332
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Intramural)
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Copyright | Published 2014. This article is a U.S. Government work and is in the public domain in the USA. |
Chemical References |
- Antibodies, Monoclonal
- Bacterial Toxins
- CA-125 Antigen
- Exotoxins
- GPI-Linked Proteins
- Glutamates
- MSLN protein, human
- SS1(dsFv)PE38
- Virulence Factors
- Pemetrexed
- Guanine
- ADP Ribose Transferases
- Pseudomonas aeruginosa exotoxin A
- Mesothelin
- Cisplatin
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Topics |
- ADP Ribose Transferases
- Aged
- Antibodies, Monoclonal
(administration & dosage, blood)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage)
- Bacterial Toxins
- CA-125 Antigen
(blood)
- Cisplatin
(administration & dosage)
- Exotoxins
- Female
- GPI-Linked Proteins
(administration & dosage, blood)
- Glutamates
(administration & dosage)
- Guanine
(administration & dosage, analogs & derivatives)
- Humans
- Lung Neoplasms
(blood, drug therapy, pathology)
- Male
- Maximum Tolerated Dose
- Mesothelin
- Mesothelioma
(blood, drug therapy, pathology)
- Mesothelioma, Malignant
- Middle Aged
- Neoplasm Staging
- Pemetrexed
- Pleural Neoplasms
(blood, drug therapy, pathology)
- Virulence Factors
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