BACKGROUND: Liposomal @entity900 preparations have two potential advantages over the free drug when combined with @entity1161 ( @entity1161 ): 1) selective tumor localization, improving the therapeutic ratio, and 2) prolonged half-life, allowing more radiosensitization. We performed a Phase I study of Stealth liposomal @entity900 ( @entity23904 ) concurrent with @entity1161 for @entity213 ( @entity213 ). METHODS: @entity1 with Stage IVa/b @entity213 were treated with @entity23904 , given intravenously twice two weeks apart, concurrent with @entity1161 (60-72 Gy in 6-7 weeks). The @entity23904 dose was escalated in standard phase I design. RESULTS: Twenty @entity1 received 38 doses of @entity23904 , escalated from 20-200 mg/m2 in six dose levels. Two of these @entity1 received one dose because of reversible Grade 3 liver @entity137 or @entity1910 . Three @entity1 had a Grade 1, and one had a Grade 2 infusion reaction. Four @entity1 had transiently elevated transaminases: Grade I (n = 1), Grade 2 (n = 1), and Grade 3 (n = 2). Grade 3 @entity1398 occurred in one @entity1 . There was no @entity2167 , @entity2359 , or nephrotoxicity. In-field radiation skin and @entity137 did not appear to be intensified. Ten of 17 @entity1 (59%) finishing treatment achieved initial complete response. CONCLUSIONS: Systemic and in-field radiation toxicities of @entity23904 were minimal. Infusion reactions were minimized with a slower and more dilute initial infusion. Further dose escalation was stopped in the absence of dose-limiting @entity137 to address the reformulation of the liposomally bound @entity900 . Nonetheless, this study shows that high doses of @entity23904 can be given safely. The potentially beneficial therapeutic ratio suggests that liposomal radiosensitizer preparations warrant further investigation.

A phase I study of @entity23904 (Stealth liposomal XXXX ) concurrent with @entity1161 for locally advanced head and neck cancer.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'mucosal toxicities'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity2167 :: ('MESH:D006311', 'Disease') :: ['ototoxicity'] @entity1161 :: ('MESH:D011832', 'Disease') :: ['radiation therapy', 'RT'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity2359 :: ('MESH:D020258', 'Disease') :: ['neurotoxicity'] @entity23904 :: ('MESH:C422270', 'Chemical') :: ['SPI-077'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity213 :: ('MESH:C535575', 'Disease') :: ['head and neck squamous cell carcinoma', 'HNSCC']
@entity900 :: (MESH:D002945,Chemical) :: ['cisplatin']
