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Quantitative Analysis of All Somatostatin Receptors and Dopamine Receptor Subtype 2 mRNA and Protein Expression Study in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vitro and in Vivo Responsiveness to Somatostatin Analogs and Dopamine Agonist


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-functioning Pituitary Adenomas, Prolactinomas

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Trial Information

Quantitative Analysis of All Somatostatin Receptors and Dopamine Receptor Subtype 2 mRNA and Protein Expression Study in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vitro and in Vivo Responsiveness to Somatostatin Analogs and Dopamine Agonist


The goals of this study are: to verify whether cabergoline and pasireotide are effective in
NFPA to control tumor re-growth as adjuvant therapy after neurosurgery and whether
pasireotide is capable of normalizing the prolactin levels in patients with prolactinomas
resistant to cabergoline; to assess the mRNA levels of DR2 and SSTR1-5 and their protein
expression; to evaluate the in vitro hormonal response to cabergoline, octreotide and
pasireotide; and to determine whether the mRNA DR2/SSTR1-5 and/or protein expression and/or
in vitro hormonal response to cabergoline, octreotide and pasireotide correlates with the in
vivo response to the former and to the last one. With this data the investigators intend to
establish if the mRNA analysis and/or protein expression in NFPA and resistant prolactinomas
might be predictive or foretelling factors concerning drug treatment in patients with this
kind of pituitary tumors and also evaluate if there is any response in vitro or in vivo to
the treatment with pasireotide in NFPA and resistant prolactinomas and with cabergoline in
NFPA.

Inclusion Criteria


Inclusion Criteria (for patients with NFPA):

- Male or female patients aged 18 years or greater;

- Patients with confirmed diagnosis of NFPA evidenced by:

- MRI confirmation of pituitary adenoma.

- No pituitary tumoral hormone hypersecretion.

- Patients with no previous medical treatment;

- Patients who had been submitted to surgery but not cured. Lack of cure is defined as
presence of remnant tumor on MRI at least three months after surgery (without any
possible misinterpretation of postsurgical changes); and

- Patients who signed the informed consent;

Inclusion Criteria (for patients with resistant prolactinomas):

- Male or female patients aged 18 years or greater;

- Patients with confirmed diagnosis of resistant prolactinoma by lack of prolactin
normalization with a tolerated cabergoline dosage during 12 weeks;

- Patients who had been submitted to surgery due to resistance to cabergoline and not
cured. Lack of cure is defined as lack of serum prolactin normalization or complete
removal of tumor load; and

- Patients who signed the informed consent.

Exclusion Criteria (for both):

- Previous pituitary radiotherapy;

- High risk for transsphenoidal surgery;

- Patients with symptomatic cholelithiasis;

- Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly
controlled as evidenced by HbA1C > 8%;

- Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits);

- Patients receiving anticoagulants that affect PT or PTT;

- Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
sustained ventricular tachycardia, clinically significant bradycardia, advanced heart
block, history of acute MI less than one year prior to study entry or clinically
significant impairment in cardiovascular function;

- Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTc
> 480 ms, hypokalemia, family history of long QT syndrome, and concomitant
medications known to prolong QT interval;

- Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic
persistent hepatitis, or patients with ALT/AST more than 2 X ULN, serum creatinine >
2.0 X ULN, serum bilirubin > 2.0 X ULN, serum albumin < 0.67 X LLN;

- Patients with WBC < 3 X 109/L; Hgb < LLN; PLT < 100 X 109/L;

- Patients who have any current or prior medical condition that can 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 for birth control. Female patients must
use barrier contraception with condoms. 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 one month after the last dose of study drug. Male patients who are sexually
active are required to use condoms during the study and for 1 month afterwards; and

- Patients who have a history of alcohol or drug abuse in the 6 month period prior to
receiving pasireotide.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor volume reduction

Outcome Description:

Magnetic resonance imaging (MRI) of the sella will be performed before and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth > 25%, stable disease as changes < 25% and significant tumor shrinkage as > 25% in tumor volume compared to baseline MRI.

Outcome Time Frame:

Six months

Safety Issue:

No

Principal Investigator

M├┤nica R. Gadelha, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Endocrinology Section - Hospital Universitário Clementino Fraga Filho/Federal University of Rio de Janeiro

Authority:

Brazil: National Health Surveillance Agency

Study ID:

CSOM230BBR01T

NCT ID:

NCT01620138

Start Date:

March 2010

Completion Date:

June 2012

Related Keywords:

  • Non-functioning Pituitary Adenomas
  • Prolactinomas
  • Non-functioning pituitary adenomas
  • Prolactinomas
  • Cabergoline
  • Pasireotide
  • somatostatin receptors
  • Dopamine receptors
  • Adenoma
  • Pituitary Neoplasms
  • Prolactinoma

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