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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somatuline Depot Subcutaneous (SC) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide | Drug | Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Remission of Acromegaly | 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. | 3 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Function | Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal. | 3 month post-op |
| Change in Hypertension | Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal |
| Measure | Description | Time Frame |
|---|---|---|
| Remission Status 1 Year After Surgery | 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. | 12 months post-op |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel F Kelly, MD | Saint John's Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute, Saint John's Health System | Santa Monica | California | 90404 | United States |
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| Label | URL |
|---|---|
| Brain Tumor Center and Pituitary Disorders Program, John Wayne Cancer Institute at Saint John's Health Center | View source |
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recruited between May 2013 and January 2016, in outpatient cancer center clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Somatuline Depot Subcutaneous (SC) | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Consented to participate in study
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| ID | Title | Description |
|---|---|---|
| BG000 | Somatuline Depot 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. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Remission of Acromegaly | 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. | 2 patients treated; data not analyzed because study terminated prematurely. | Posted | 3 months post-op |
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somatuline Depot 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. lanreotide: Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Kelly | JOHN WAYNE CANCER INSTITUTE | 310-582-7450 | Daniel.Kelly2@providence.org |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D005877 | Gigantism |
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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| 3 months |
| Change in Respiratory Function | Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal | 12 weeks and 3 months |
| Change in Quality of Life | Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal | 3 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Change in Cardiac Function | Changes in cardiac function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal. | 2 patients treated; data not analyzed because study terminated prematurely. | Posted | 3 month post-op |
|
|
| Secondary | Change in Hypertension | Change in hypertension after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal | 2 patients treated; data not analyzed because study terminated prematurely. | Posted | 3 months |
|
|
| Secondary | Change in Respiratory Function | Change in respiratory function after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal | 2 patients treated; data not analyzed because study terminated prematurely. | Posted | 12 weeks and 3 months |
|
|
| Secondary | Change in Quality of Life | Change in Quality of Life after 12 weeks of Somatuline therapy and 3 months after endonasal endoscopic adenoma removal | 2 patients treated; data not analyzed because study terminated prematurely. | Posted | 3 months |
|
|
| Other Pre-specified | Remission Status 1 Year After Surgery | 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. | 2 patients treated; data not analyzed because study terminated prematurely. | Posted | 12 months post-op |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment | ears feel full of water |
|
| pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | due to blood loss during surgery |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | anosmia |
|
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D001848 | Bone Diseases, Developmental |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |