Lanreotide for Pheochromocytoma / Paraganglioma

(LAMPARA Trial)

Recruiting at 2 trial locations

Overseen By Antonio Fojo, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Antonio Fojo

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Uncontrolled diabetes, Hypertension, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 32-48 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken certain treatments like cytotoxic chemotherapy or specific therapies like sunitinib within a certain period before starting the study. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Lanreotide for treating pheochromocytoma or paraganglioma?

While there is no direct evidence for Lanreotide, similar drugs like octreotide, which are also somatostatin analogs, have shown benefits in treating paragangliomas by reducing symptoms and tumor activity. ^{1 2 3 4 5}

How does the drug Lanreotide differ from other treatments for pheochromocytoma/paraganglioma?

Lanreotide is similar to octreotide, a drug that has shown benefits in managing symptoms and controlling hormone levels in paragangliomas, which are rare tumors. Lanreotide, like octreotide, is a somatostatin analog that can help manage these tumors by reducing hormone secretion, potentially offering a novel approach for patients with these conditions. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Antonio Fojo, MD, PhD

Principal Investigator

Columbia University

Eligibility Criteria

Adults with advanced or metastatic paraganglioma/pheochromocytoma, who have shown recent disease progression and are somatostatin receptor positive. They must be in good enough health to participate (ECOG 0-2), not pregnant, willing to use contraception if of childbearing potential, and have a life expectancy over 12 weeks. Prior treatments like surgery should be completed at least 28 days before joining.

Inclusion Criteria

You are able to carry out everyday activities without needing help.

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

Exclusion Criteria

Any serious medical condition that could jeopardize the safety of the patient and/or the efficacy assessments of the study

You have had a heart attack, unstable chest pain, or worsening heart failure in the last 28 days.

You have a known allergy to the investigational drug or similar medications like Lanreotide or octreotide.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lanreotide every 4 weeks to assess efficacy, toxicity, and safety in advanced or metastatic paraganglioma/pheochromocytoma

32-48 weeks

Visits every 4 weeks for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Lanreotide

Trial Overview The trial is testing the effectiveness and safety of lanreotide administered every four weeks on patients with pheochromocytoma/paraganglioma. It will compare tumor growth rates before and after treatment, survival times without disease progression, response rates to treatment, and changes in specific biochemical markers.

Participant Groups

Group I: lanreotide arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Antonio Fojo

Lead Sponsor

Trials

3

Recruited

20+

Ipsen

Industry Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

References

1. United States pubmed.ncbi.nlm.nih.gov

Hypertensive Crisis in a Patient With a Functioning Mesenteric Paraganglioma: Dramatic Response to Octreotide Treatment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of octreotide therapy in progressive head and neck paragangliomas: case series. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Malignant pheochromocytomas and paragangliomas - the importance of a multidisciplinary approach. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of a malignant sympathetic paraganglioma of the organ of Zuckerkandl--a case report]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of a large series of patients surgically treated for pheochromocytoma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Catecholamine-secreting carotid body paraganglioma: successful preoperative control of hypertension and clinical symptoms using high-dose long-acting octreotide. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Glomus Tumor of the Larynx: A Rare Synchronous Paraganglioma in a Patient with Bilateral Carotid Body Tumor Detected on 68Ga-DOTANOC PET/CT. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Late-Detected Paraganglioma in a Young Patient with Resistant Hypertension and Severe Aortic Regurgitation-A Case Report and Review of the Literature. [2023]