Phase 2
Completed N=4
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
lymphangioleiomyomatosis · Lymphangiomyomas · Pleural Effusions · ascites
Source: ClinicalTrials.gov NCT00005906 ↗
Enrolled (actual)
4
Serious AEs
25.0%
Results posted
Apr 2010
Primary outcomePrimary: Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. — 0 Participants
Summary
Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous effusions and lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings have shown reduction in chylous effusions. This study assesses the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Reduction in Total Tumor Volume of at Least 20%. |
— | — |
| PRIMARY Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms. |
1 | — |
| SECONDARY Number of Participants With Liver Function Abnormalities |
1 | — |
Eligibility Criteria
- INCLUSION CRITERIA:
Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following:
- lymphangioleiomyomas
- chylous pleural effusions
- peripheral lymph-edema
- chyloptysis
- protein-losing enteropathy
- chyluria
Patients will be included in this protocol if symptoms are attributed to the above processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other endocrine-related disorders will be included if justified clinically based on severity of symptoms.
EXCLUSION CRITERIA
- Hypersensitivity to somatostatin, octreotide or its analogues
- Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases
- Transplant patients
- Pregnant women or women who are beast-feeding
- Patient or another responsible party is unable to give the subcutaneous injection
- Patient unwilling to be followed per the guidelines set forth
- Patients with decreased renal function (creatinine greater than 1.5)
- Patients with HIV infection
- Immunosuppressed patients
Data sourced from ClinicalTrials.gov (NCT00005906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.