Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Thymoma Clinical Trial

Official title:

Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332969
• Other study ID #: CSMS995ADE13
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2006
• Last updated: March 30, 2017
• Start date: September 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

Intervention

Drug:
• Octreotide

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Ströbel 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 Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shrinkage of tumor size and diameter of 3 respectively 6 months		6 months
Secondary	Resection status after 3 respectively 6 months		3 - 6 months

External Links

•   Results for CSMS995ADE13 on the Novartis Clinical Trials Website