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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Regensburg
Sponsor:
Collaborator:
Crolll Gmbh
Information provided by (Responsible Party):
Prof. Dr. Berthold Schalke, University of Regensburg
ClinicalTrials.gov Identifier:
NCT02021942
First received: December 20, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Primary Inoperable Thymoma
Local Recurrent Thymoma
Drug: SOM230 LAR
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Tumor shrinkage [ Time Frame: at least 6 months ] [ Designated as safety issue: No ]
    To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume.


Secondary Outcome Measures:
  • Resection status [ Time Frame: at least 6 months ] [ Designated as safety issue: No ]
    To evaluate the resection status based on the categories R0, R1 and ≥ R2.

  • Histological changes (necrosis) [ Time Frame: at least 6 months ] [ Designated as safety issue: No ]
    1. percentage of necrotic area
    2. degree of depletion (none, slight; moderate; marked) of immature T-cells (immunohistochemistry for CD1a, CD99, CD3 expression)
    3. change of T-cell subset composition as revealed by FACS analysis

  • Safety [ Time Frame: at least 6 months ] [ Designated as safety issue: Yes ]
    The assessment of safety will be based mainly on the frequency of Adverse Events and on the number of laboratory values that fall outside of pre-determined ranges.


Estimated Enrollment: 16
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOM230 LAR
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Drug: SOM230 LAR
SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.
Other Names:
  • Pasireotide
  • Sandostatin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Patients with QT related risk factor: Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant / symptomatic bradycardia, or high-grade AV block
  • Patients with QT related risk factor: Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Patients with QT related risk factor: Concomitant medication(s) known to increase the QT interval
  • Patients with potassium <3.0 mmol/L at study entry, magnesium <0.4 mmol/L at study entry, calcium <1.75 mmol/L at study entry, family history of long QT syndrome, and concomitant medications known to prolong the QT interval. If the electrolyte abnormalities are corrected prior to study commencement, the patient may become eligible for the trial.
  • Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, serum albumin < 0.67 X LLN, and/or ALT or AST more than 2 X ULN for patients without liver Confidential - 20 - Amended Clinical Study Protocol v01 / Track Changes Study No. CSOM230CIC01T metastases or ALT or AST more than 5X ULN for patients with documented liver metastases
  • Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
  • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
  • Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits)
  • Patients with WBC <2.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L (patients with paraneoplastic pan-, leuco-, erythro- or thrombopenia can be included if this seems to be the only reason for pan-, leuco-, erythro- or thrombopenia)
  • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations
  • Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
  • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use a secure method of contraception if sexually active and the partner should use a condom. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs). Female partners of these male patients should use a secondary barrier contraception.
  • Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
  • Patient has received any other investigational agents within 28 days of first day of study drug dosing
  • Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021942

Locations
Germany
Klinik und Poliklinik für Neurologie der Universität Regensburg Recruiting
Regensburg, Bavaria, Germany, 93053
Contact: Berthold Schalke    ++49 941 941 ext 3010    Berthold.Schalke@medbo.de   
Contact: Theresa Birkl    ++49 941 - 941 ext 3003    theresa.birkl@medbo.de   
Sub-Investigator: Sandra Boy         
Sub-Investigator: Lukas Kirzinger         
Sub-Investigator: Rosemary Kollanur         
Principal Investigator: Berthold Schalke         
Sponsors and Collaborators
Prof. Dr. Berthold Schalke
Crolll Gmbh
  More Information

No publications provided

Responsible Party: Prof. Dr. Berthold Schalke, University of Regensburg
ClinicalTrials.gov Identifier: NCT02021942     History of Changes
Other Study ID Numbers: CSOM230CIC01T
Study First Received: December 20, 2013
Last Updated: December 20, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:
primary inoperable thymoma
local recurrent thymoma
reduction of tumor size
SOM230 LAR

Additional relevant MeSH terms:
Thymoma
Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014