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Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Primary Purpose

Thymoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Octreotide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma focused on measuring Open label, phase II, disease, clinical trial, Octreotide, thymoma, cancer, tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sandostatin

Arm Description

Outcomes

Primary Outcome Measures

Shrinkage of tumor size and diameter of 3 respectively 6 months

Secondary Outcome Measures

Resection status after 3 respectively 6 months

Full Information

First Posted
June 1, 2006
Last Updated
March 30, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00332969
Brief Title
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
Official Title
Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma
Keywords
Open label, phase II, disease, clinical trial, Octreotide, thymoma, cancer, tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sandostatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Octreotide
Primary Outcome Measure Information:
Title
Shrinkage of tumor size and diameter of 3 respectively 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Resection status after 3 respectively 6 months
Time Frame
3 - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Regensburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27992479
Citation
Kirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Strobel P, May C, Kleylein-Sohn J, Baierlein C, Bogdahn U, Marx A, Schalke B. Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Recurrent Unresectable Thymic Tumors: A Phase II Study. PLoS One. 2016 Dec 16;11(12):e0168215. doi: 10.1371/journal.pone.0168215. eCollection 2016.
Results Reference
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Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

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