Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Inclusion criteria

• Male or female patients aged >18 years
• Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.
• Positive result in SMS-szintigraphy,
• Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.
• Patients with and without thymoma associated paraneoplastic syndrome
• Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

Exclusion criteria

• Performance status 0,1, or 2 (ECOG)
• Symptomatic cholelithiasis,
• Pretreatment with octreotide (longn acting release) within the 3 months
• Patient has received any other investigational agents within 28 days of first day of study drug dosing
• Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
• Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)

Other protocol-defined inclusion/exclusion criteria apply