A Pilot Study of Pre- and Post-operative Use of Somatuline Depot.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Somatuline Depot Subcutaneous (SC) Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. |
Drug: lanreotide
Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Early Remission of Acromegaly [3 months post-op]
Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test.
Secondary Outcome Measures
- Change in Cardiac Function [3 month post-op]
Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal.
- Change in Hypertension [3 months]
Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Change in Respiratory Function [12 weeks and 3 months]
Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
- Change in Quality of Life [3 months]
Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal
Other Outcome Measures
- Remission Status 1 Year After Surgery [12 months post-op]
Remission status one year after surgery and time to achieve remission in patients who did not achieve remission after endonasal endoscopic surgery and who had resumption of Somatuline Depot therapy 3 months after surgery.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System | Santa Monica | California | United States | 90404 |
Sponsors and Collaborators
- Saint John's Cancer Institute
Investigators
- Principal Investigator: Daniel F Kelly, MD, Saint John's Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KELD-ESS-0413
Study Results
Participant Flow
| Recruitment Details | recruited between May 2013 and January 2016, in outpatient cancer center clinic |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Somatuline Depot Subcutaneous (SC) |
|---|---|
| Arm/Group Description | Somatuline Depot Subcutaneous (SC) 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Period Title: Overall Study | |
| STARTED | 4 |
| COMPLETED | 2 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Somatuline Depot SC |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Overall Participants | 4 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
4
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
50%
|
| Male |
2
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
3
75%
|
| Unknown or Not Reported |
1
25%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
4
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
4
100%
|
Outcome Measures
| Title | Early Remission of Acromegaly |
|---|---|
| Description | Early remission status after a 12 week course of pre-operative Somatuline Depot and 3 months after endonasal endoscopic surgery. Remission status will be based on age-adjusted Insulin Glucose Factor 1 (IGF-1) levels and oral glucose tolerance test. |
| Time Frame | 3 months post-op |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients treated; data not analyzed because study terminated prematurely. |
| Arm/Group Title | Somatuline Depot Subcutaneous (SC) |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Measure Participants | 0 |
| Title | Change in Cardiac Function |
|---|---|
| Description | Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal. |
| Time Frame | 3 month post-op |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients treated; data not analyzed because study terminated prematurely. |
| Arm/Group Title | Somatuline Depot SC |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Measure Participants | 0 |
| Title | Change in Hypertension |
|---|---|
| Description | Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients treated; data not analyzed because study terminated prematurely. |
| Arm/Group Title | Somatuline Depot SC |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Measure Participants | 0 |
| Title | Change in Respiratory Function |
|---|---|
| Description | Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal |
| Time Frame | 12 weeks and 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients treated; data not analyzed because study terminated prematurely. |
| Arm/Group Title | Somatuline Depot SC |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Measure Participants | 0 |
| Title | Change in Quality of Life |
|---|---|
| Description | Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients treated; data not analyzed because study terminated prematurely. |
| Arm/Group Title | Somatuline Depot SC |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Measure Participants | 0 |
| Title | Remission Status 1 Year After Surgery |
|---|---|
| Description | Remission status one year after surgery and time to achieve remission in patients who did not achieve remission after endonasal endoscopic surgery and who had resumption of Somatuline Depot therapy 3 months after surgery. |
| Time Frame | 12 months post-op |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients treated; data not analyzed because study terminated prematurely. |
| Arm/Group Title | Somatuline Depot SC |
|---|---|
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Measure Participants | 0 |
Adverse Events
| Time Frame | 15 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Somatuline Depot SC | |
| Arm/Group Description | Somatuline Depot SC 90mg deep subcutaneous injection every 4 weeks for 3 doses before surgery. The dose will be 60 mg for patients with mild liver or kidney dysfunction. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses | |
All Cause Mortality |
||
| Somatuline Depot SC | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | |
Serious Adverse Events |
||
| Somatuline Depot SC | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Somatuline Depot SC | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | |
| Blood and lymphatic system disorders | ||
| anemia | 1/2 (50%) | 1 |
| Ear and labyrinth disorders | ||
| Ear and labyrinth disorders - Other, specify | 1/2 (50%) | 1 |
| Eye disorders | ||
| blurred vision | 1/2 (50%) | 1 |
| Gastrointestinal disorders | ||
| abdominal pain | 1/2 (50%) | 1 |
| Gastrointestinal pain | 1/2 (50%) | 1 |
| General disorders | ||
| pain | 1/2 (50%) | 1 |
| fatigue | 1/2 (50%) | 1 |
| Investigations | ||
| weight loss | 1/2 (50%) | 1 |
| Metabolism and nutrition disorders | ||
| anorexia | 1/2 (50%) | 1 |
| Nervous system disorders | ||
| Headache | 2/2 (100%) | 2 |
| Dysgeusia | 1/2 (50%) | 1 |
| Nervous system disorders - Other, specify | 1/2 (50%) | 1 |
| Renal and urinary disorders | ||
| urinary frequency | 2/2 (100%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| nasal congestion | 1/2 (50%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Daniel Kelly |
|---|---|
| Organization | JOHN WAYNE CANCER INSTITUTE |
| Phone | 310-582-7450 |
| Daniel.Kelly2@providence.org |
- KELD-ESS-0413