LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)

NCT03946527 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAS2820
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Paraganglioma; Pheochromocytoma

Keywords

advanced paraganglioma; advanced pheochromocytoma; metastatic paraganglioma; metastatic pheochromocytoma; lanreotide

Outcome Measures

Primary Outcomes (1)

• Rate of tumor growth

  Efficacy will be assessed by measuring the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrollment growth rates. Tumor growth measured by a CT or MRI scan in pre-treatment, and minimum of three scans (prior to every 3rd visit, or every 12 weeks) in post-treatment.

  minimum of 32 weeks, up to 48 weeks

Secondary Outcomes (4)

• Overall survival (OS)

  Observed for 48 weeks (start of treatment to end of treatment).

• Overall Response Rate (ORR)

  Minimum of 8 weeks, up to 48 weeks.

• Progression-free survival

  Up to 48 weeks.

• Magnitude of change in analyte levels

  Minimum of 16 weeks, up to 48 weeks.

Study Arms (1)

lanreotide arm

EXPERIMENTAL

Patients with a histopathologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability who meet the inclusion/exclusion criteria. Approximately 40 patients will be enrolled.

Drug: Lanreotide

Interventions

Lanreotide DRUG

Participants will receive lanreotide 120 mg deep subcutaneous injection every 4 weeks (±7 days) for 52 weeks, followed by an extension phase in which all patients will continue to receive lanreotide 120 mg injection every 4 weeks (±7 days) if there is no evidence of disease progression.

Also known as: Somatuline Depot

lanreotide arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age at the time of first dosing
• Patients must give signed informed consent before any study-related activities are conducted.
• 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.
• Histologically or cytologically confirmed diagnosis of malignant paraganglioma or pheochromocytoma and either evidence of metastases or unresectability.
• 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.
• 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
• 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).
• Patients may not have had prior octreotide, long acting release (LAR)-octreotide, lanreotide or a therapeutic radiolabeled somatostatin analog (PRRT)
• Eastern Cooperative Oncology Group (ECOG) 0-2.
• Life expectancy of greater than 12 weeks.
• Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 2 x the upper limit
• Patients may have had prior radiation therapy. A minimum of 42 days must have elapsed between the end of radiotherapy and registration onto the study. Measurable disease must exist outside of the radiation field for eligibility.
• Previous surgery: Previous major surgery is permitted provided that it was performed at least 28 days prior to patient registration.
• Laboratory requirements \[parameter limits\]: Absolute granulocyte count (AGC) greater than 1.5 x 109/L; platelet count greater than100 x 109/L; serum bilirubin less than 1.5 x upper limit of normal (ULN); serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; serum amylase less than1.5 x ULN; serum lipase less than 1.5 x ULN; serum calcium less than 3 mmol/L; serum creatinine less than 1.5 x ULN
• If female, the patient must not be pregnant (confirmed by negative pregnancy test) and must have the following documented via verbally given history:

You may not qualify if:

• A patient who meets any of the following criteria is ineligible for participation in the study:
• 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
• 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
• 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).
• 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.
• 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.
• 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).
• 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)
• Uncontrolled cardiac disease (acute myocardial infarction, unstable angina or hospitalization for decompensation of congestive heart failure within the 28 days prior to the start of study therapy (lanreotide).
• Any malignancies except:
• Basal cell carcinoma of the skin
• In situ carcinoma of the cervix
• years disease-free after curative cancer treatment (completion of surgery, adjuvant chemotherapy and/or radiation, and considered no evidence of disease from non phaeochromocytomas and paragangliomas (PPGL) malignancy)

Sponsors & Collaborators

• Antonio Fojo: lead
• Ipsen: collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Paraganglioma; Pheochromocytoma

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Antonio Fojo, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine at the Columbia University Medical Center, Dept of Med Hematology & Onc

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: June 17, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (2)