Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size

Prof. Dr. Berthold Schalke1 site in 1 country16 target enrollmentMarch 2012

ConditionsPrimary Inoperable Thymoma Local Recurrent Thymoma

InterventionsSOM230 LAR

DrugsSOM230 LAR

Overview

Phase: Phase 2
Intervention: SOM230 LAR
Conditions: Primary Inoperable Thymoma
Sponsor: Prof. Dr. Berthold Schalke
Enrollment: 16
Locations: 1
Primary Endpoint: Percent Change in Tumor Volume From Baseline to EOS
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230 LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose of this trial is a proof of concept.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

October 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Prof. Dr. Berthold Schalke

Responsible Party

Sponsor Investigator

Principal Investigator

Prof. Dr. Berthold Schalke

University of Regensburg

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged ≥18 years
•Diagnosis of thymoma as assessed by biopsy and/or szintigraphy
•Inoperability of thymoma or loco-regional metastases. Inoperability is defined as at least adherence of the tumor to the neighbored organs, suspicious to infiltrate neighbored organs or local metastasis so that R0 resection can not be expected and /or local recurrence of thymic tumor
•Tumor stage: Thymomas of all WHO based histological subtypes (WHO A, AB, B1, B2, B3) (Rosai, 1999; Travis 2004) at Masaoka stage II to IVa based on histological examination of resection specimens or core biopsies.
•Patients with and without thymoma associated paraneoplastic syndrome.
•Performance status 0,1, or 2 (ECOG)
•Patients for whom written informed consent to participate in the study has been obtained

Exclusion Criteria

•Patients having received radiolabeled somatostatin analogue therapy within the 6 months or any cytotoxic chemotherapy or interferon therapy within the 2 months prior to recording baseline symptoms
•Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months before recording baseline symptoms
•Patients who have received radiotherapy for any reason within the last 4 weeks and must have recovered from any side effects of radiotherapy before recording baseline symptoms
•Patients who are not biochemically euthyroid
•Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as indicated by HbA1C \> 8%
•Patients with symptomatic cholelithiasis
•Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
•Patients with QT related risk factor: QTcF at screening \> 450 msec
•Patients with QT related risk factor: History of syncope or family history of idiopathic sudden death
•Patients with QT related risk factor:Sudden or clinically significant cardiac arrhythmias

Arms & Interventions

SOM230 LAR

SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks

Intervention: SOM230 LAR

Outcomes

Primary Outcomes

Percent Change in Tumor Volume From Baseline to EOS

Time Frame: at least 6 months

To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.