Status:
COMPLETED
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Thymoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00332969
Start Date
September 1 2005
Last Update
March 31 2017
Active Locations (1)
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1
Novartis Investigative Site
Regensburg, Germany