Acromegaly Combination Treatment Study
Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Intervention: Pegvisomant (Drug); Somatostatin Receptor Ligand (SRL) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Cedars-Sinai Medical Center Official(s) and/or principal investigator(s): Shlomo Melmed, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center
Overall contact: Vivian Hwe, Phone: 424-315-4489, Email: hwev@cshs.org
Summary
In this study the investigators will evaluate whether combination low dose somatostatin
receptor ligand (SRL) and weekly or daily Pegvisomant will attain equivalent control of
serum IGF-1 levels, compared to combination high dose SRL and weekly Pegvisomant. Lower
doses of therapy will greatly reduce cost of acromegaly therapy.
Clinical Details
Official title: Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy and High-Dose SRL + Weekly Pegvisomant Therapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Equivalent Control
Detailed description:
The study will begin when the combination of Sandostatin LAR or Somatuline and pegvisomant
is first administered. Study visits will occur every 4 weeks from the start of the study.
However, for subjects who cannot make every study visit due to distance, the study team will
facilitate monthly blood draws at their local Quest laboratory facility.
After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start
Pegvisomant monotherapy at the same dose that they attained normalization in combination
therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly.
An MRI will be performed at the conclusion of the 48 week treatment period.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Newly diagnosed patients with acromegaly who have not had surgery or medical therapy
- Acromegaly patients who are at least 3 months post surgery, who are/are not receiving
adjuvant medical therapy
- Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels
- Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.
- Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6
week washout period of the dopamine agonist.
- Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant
(daily or weekly
- Normal liver function tests before randomization to treatment
- The patient has had appropriate dynamic testing of the pituitary axis and, if
applicable, is receiving appropriate hormone replacement therapy.
Exclusion Criteria:
- The patient harbors a macroadenoma with visual field defects due to chiasmatic
compression
- The patient has clinically significant hepatic abnormalities and/or aspartate
aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper
limit of normal at the baseline visit.
- The patient had pituitary surgery within 3 months prior to study entry
- The patient had radiotherapy within 12 months prior to study entry
- The patient has abnormal CBC and chemistry panel at the baseline visit, any other
medical condition(s) or laboratory findings that, in the opinion of the investigator,
might jeopardize the patient's safety.
- The patient has a known hypersensitivity to any of the test materials or related
compounds.
- The patient has a history of, or known current problems with alcohol or drug abuse.
- The patient has any mental condition rendering the patient unable to understand the
nature, scope, and possible consequences of the study, and/or evidence of an
uncooperative attitude.
Locations and Contacts
Vivian Hwe, Phone: 424-315-4489, Email: hwev@cshs.org
Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting Vivien Bonert, MD, Sub-Investigator
Additional Information
Starting date: January 2012
Last updated: February 2, 2015
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