Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Novartis

Status and phase

Completed

Phase 2

Conditions

Thymoma

Treatments

Drug: Octreotide

Study type

Interventional

Funder types

Industry

Identifiers

CSMS995ADE13

Details and patient eligibility

About

This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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