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LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

Exploratory Phase II Study of LAnreotide in Metastatic Pheochromocytoma/PARAganglioma (LAMPARA)

NCT03946527•Antonio Fojo

Summary

The objectives of this study are: * To assess the efficacy of lanreotide given every 4 weeks in participants with advanced or metastatic paraganglioma/ pheochromocytoma. * To assess the toxicity and safety of lanreotide in participants with advanced or metastatic paraganglioma/ pheochromocytoma. * To document the effects of lanreotide on markers of biochemical activity in participants with advanced or metastatic paraganglioma/ pheochromocytoma. Primary endpoints: • Assess efficacy by estimating the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrolment growth rate. Secondary endpoints include measurement of: * Overall survival (OS) * Progression-free survival (PFS) * Overall response rate (ORR) according to RECIST defined as partial response (PR) + complete response (CR) * Magnitude of reduction in levels of 24-hour urinary metanephrines, catecholamines and magnitude of reduction in serum chromogranin A, evaluated every two months while enrolled on study.

Detailed Description

Lanreotide is FDA approved for certain kinds of neuroendocrine tumors. This study seeks to determine if lanreotide is beneficial for patients with paraganglioma/ pheochromocytoma. Given the rarity of pheochromocytoma/paraganglioma that precludes the conduct of a randomized clinical trial in a timely manner, a novel method for assessing efficacy is being proposed. Efficacy will be assessed by estimating the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrollment growth rates. The method of analysis that will be used has been previously described. For this assessment a minimum of three tumor measurements will be required.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For inclusion in the study, patients must fulfill all of the following criteria:
•1. Male or female at least 18 years of age at the time of first dosing
•2. Patients must give signed informed consent before any study-related activities are conducted.
•3. Patients in the United States must have given written authorization for the release of protected health information in compliance with HIPAA regulations; patients in other countries must provide appropriate authorization as needed by regulatory authorities in each country.
•4. Histologically or cytologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability.
•5. Evidence of recent disease progression (radiological, biochemical, symptomatic) while the patient was either not receiving any therapy or was receiving a therapy that was deemed ineffective.
•6. Measurable disease defined as that which can be measured in at least one dimension with a minimum size of 10 mm by CT scan. The patient must also have at least three baseline radiographic studies obtained in the previous twelve months with at least one scan obtained within six weeks of enrollment. If a patient being considered for enrollment on trial has not had three scans performed in the twelve months prior to enrollment and if in the opinion of the investigator a delay of one month will not impact the clinical course, then enrollment on protocol and the start of the lanreotide therapy can be delayed by one month or longer to obtain the additional time point. If in the opinion of the investigator such a delay may have adverse consequences then enrollment on the protocol should not be considered as an option
•7. Confirmation of positive somatostatin receptor status (SRS) by Somatostatin Receptor Scintigraphy. Either of these studies will need to have been performed in the 6 months prior to the screening visit. Only if one has not been performed within the previous 6 months will a SRS study be required. if an SRS is required, it will be performed greater than or equal to 24 hours after a previous injection of subcutaneous octreotide).
•8. Patients may not have had prior octreotide, long acting release (LAR)-octreotide, lanreotide or a therapeutic radiolabeled somatostatin analog (PRRT)
•9. Eastern Cooperative Oncology Group (ECOG) 0-2.
+11 more criteria

Exclusion Criteria

•A patient who meets any of the following criteria is ineligible for participation in the study:
•1. Patient has a history of known allergy or hypersensitivity to:
•* Investigational drug or any components of its formulation
•* Lanreotide, octreotide or any other somatostatin analog
•2. Treatment with any other investigational drug or with "cytotoxic chemotherapy" within 28 days prior to the start of study therapy (lanreotide) and/or at any time during the patient's participation in the study
•3. Treatment with sunitinib, radiotherapy, a radiolabelled specific somatostatin receptor (SSTR) analog, and/or tumor debulking less than 14 days prior to the start of study therapy (lanreotide). Treatment with metaiodobenzylguanidine (MIBG) therapy less than 90 days prior to the start of study therapy (lanreotide).
•4. History of hepatic arterial embolization or hepatic arterial chemoembolization less than 28 days prior to the start of study therapy (lanreotide). Measurable disease shall exist outside of treated lesions for eligibility.
•5. History of hepatic selective internal radiation therapy (e.g. Sir-spheres) less than 90 days prior the start of study therapy (lanreotide). Measurable disease shall exist outside the liver for eligibility.
•6. Uncontrolled diabetes (defined as inability to maintain fasting blood glucose levels below 200 mg/dL despite best medical therapy, within last 28 days prior to screening) and/or hypertension (defined as inability to maintain blood pressure levels below systolic 140 mm Hg and/or diastolic 90 mm Hg on at least three antihypertensive medications, within last 28 days prior to screening).
•7. Renal impairment (glomerular filtration rate less than 30 ml/min/1.73m2) and/or liver impairment (serum total bilirubin greater than 1.5 x ULN, or greater than 2.5 x ULN if liver metastases)
+6 more criteria

Locations (2)

Columbia University Irving Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

June 17, 2019

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

ParagangliomaPheochromocytoma

Interventions

Lanreotide

DRUG

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

NCT04924075

Pheochromocytoma/ParagangliomaPancreatic Neuroendocrine Tumor+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

Inclusion Criteria

Exclusion Criteria

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Familial Investigations of Childhood Cancer Predisposition

Institutional Registry of Rare Diseases

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma

The Incidence and Outcomes of Metabolically Active Brown Adipose Tissue (aBAT) in Patients With Pheochromocytoma or Paraganglioma (PPGLs)