Overview

Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Octreotide

Criteria

Inclusion Criteria:

1. Male or female patients aged >18 years

2. 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.

3. Positive result in SMS-szintigraphy,

4. 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.

5. Patients with and without thymoma associated paraneoplastic syndrome

6. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

Exclusion Criteria:

1. Performance status 0,1, or 2 (ECOG)

2. Symptomatic cholelithiasis,

3. Pretreatment with octreotide (longn acting release) within the 3 months

4. Patient has received any other investigational agents within 28 days of first day of
study drug dosing

5. 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

6. 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