Clinical trial NCT01861717: A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Official title: A Pilot Study of Pre- and Post-operative Somatuline Depot Therapy in Acromegalic Patients Treated by Endonasal Endoscopic Surgery: Impact on Early Remission Rates and Perioperative Morbidity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acromegaly
Keywords: excess growth hormone
excess GH
gigantism
pituitary tumor
pituitary adenoma
growth hormone tumor
GH secreting adenoma
Somatuline
lanreotide
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth hormone) the treatment is to have it surgically removed. This study has two phases.

The first phase provides medical treatment with a drug that will be provided for 3 months before surgery to see if complications of surgery are reduced and to see whether or not remission improves following surgery if you have this medical treatment. The drug administered is approved by the FDA for long-term treatment of acromegaly. It is not routinely administered before surgery, and is therefore experimental as used in this way. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The second phase of this study is from 3 months until 12 months after surgery and is only for people who do not go into remission after the operation. This phase assesses the possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9 months. The drug will be prescribed by your physician as part of your regular medical care and will not be included as part of the study. All other procedures performed during this research are standard of care with the exception of the 3 questionnaires to be completed at each visit.

The study lasts approximately 16 months - 3 month before surgery and 12 months after surgery.


Eligibility criteria: Inclusion Criteria:

* age 18 - 75
* elevated serum Insulin-like growth factor-1 (IGF-1) level above age- and sex-based normal values and failure of growth hormone(GH) suppression to \< 1.0 ng/ml after a 75 gm oral glucose tolerance test (OGTT) American Association of Clinical Endocrinolgists (AACE) Acromegaly Clinical Guidelines 2004
* visible pituitary adenoma (microadenoma or macroadenoma) on high quality pituitary MRI without and with gadolinium
* prior treatments for acromegaly with surgery, somatostatin analogs or pegvisomant are acceptable if these therapies have been discontinued for at least 3 months prior to study entry

Exclusion Criteria:

* Age \< 18 or \> 75 years
* acromegalic patients currently on a lanreotide or octreotide preparation or on pegvisomant
* patients who have received prior radiotherapy or radiosurgery
* patients with adenoma-related visual acuity or visual field deficit from optic nerve and/or chiasm compression or severe optic nerve/chiasm compression in the setting of normal visual fields and acuity
* patients with pituitary apoplexy defined as recent tumor hemorrhage and/or infarction on MRI with associated symptoms of new onset visual loss, diplopia and/or adrenal insufficiency

Primary outcomes:
measure: Early Remission of Acromegaly
timeFrame: 3 months post-op
Secondary outcomes:
measure: Change in Cardiac Function
timeFrame: 3 month post-op
measure: Change in Hypertension
timeFrame: 3 months
measure: Change in Respiratory Function
timeFrame: 12 weeks and 3 months
measure: Change in Quality of Life
timeFrame: 3 months
Other outcomes:
measure: Remission Status 1 Year After Surgery
timeFrame: 12 months post-op
Locations:
city: Santa Monica
country: United States
facility: Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Daniel F Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: