Lanreotide for Pheochromocytoma / Paraganglioma

(LAMPARA Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of lanreotide, a somatostatin analog, for individuals with advanced or metastatic paraganglioma or pheochromocytoma, which are rare tumors. The study also assesses the safety of lanreotide and its potential side effects. Researchers will monitor participants' tumor growth and levels of certain chemicals in their bodies to evaluate lanreotide's effectiveness. Suitable candidates for this trial include those with a confirmed diagnosis of malignant paraganglioma or pheochromocytoma that has spread or cannot be surgically removed, and whose condition has recently worsened. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in treatment.

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.

Is there any evidence suggesting that lanreotide is likely to be safe for humans?

Research shows that lanreotide is generally safe, as the FDA has approved it for certain types of tumors. This approval indicates thorough safety testing in other conditions. Studies have found that patients tolerate lanreotide well.

Most people experience only mild side effects, such as reactions at the injection site, mild stomach issues, or fatigue. Serious side effects are rare but can include gallstones or changes in blood sugar levels. Regular check-ups are important to monitor any side effects.

While researchers continue to study lanreotide specifically for paraganglioma and pheochromocytoma, existing evidence from its use in other conditions suggests it is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lanreotide is unique because it offers a different approach to treating malignant pheochromocytoma and paraganglioma. Unlike standard treatments that often rely on surgery or chemotherapy, lanreotide is a somatostatin analog, which helps regulate hormones that can contribute to tumor growth. Researchers are excited about lanreotide because it has the potential to manage symptoms and slow down tumor progression with a different mechanism of action, offering hope for patients with advanced, non-resectable, or metastatic forms of these rare tumors.

What evidence suggests that lanreotide might be an effective treatment for pheochromocytoma/paraganglioma?

Research has shown that lanreotide can slow the growth of certain tumors, including those associated with genetic conditions. In some cases, it has completely halted tumor growth, improving symptoms such as high blood pressure and rapid heart rate. This trial will assess lanreotide's effectiveness in managing conditions like pheochromocytoma and paraganglioma. Evidence suggests that lanreotide may effectively control the progression of these rare cancers. ^{1 2 3 6 7}

Who Is on the Research Team?

Antonio Fojo, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03946527

Study Details | NCT03946527 | LAnreotide in Metastatic ... The objectives of this study are: To assess the efficacy of lanreotide given every 4 weeks in participants with advanced or metastatic paraganglioma/ ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02729-7/fulltext

1151P Biochemical and radiological efficacy of systmic ... Lanreotide autogel therapy is effcient in reducing TGR in all subjects. TGR reduction is seen in a group of secretory tumors, hereditary syndromes and also ...

3. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=000305-C&&query=Rare

NIH Clinical Center: Search the Studies Exploratory Phase II Study of LAnreotide in Unresectable or Metastatic Pheochromocytoma / PARAganglioma. This study is NOT currently recruiting participants.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214624517300151

Successful induction therapy with sequential CVD followed ... Bimonthly lanreotide in monotherapy resulted in a complete clinical response including control of her blood pressure (110/72 mm/Hg) and heart rate (83 bpm).

5. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03946527/

Clinical Trial: NCT03946527 This study seeks to determine if lanreotide is beneficial for patients with paraganglioma/ pheochromocytoma. Given the rarity of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03946527?term=pheochromocytoma%20OR%20paraganglioma%20AND%20NICHD&viewType=Table&rank=10

LAnreotide in Metastatic Pheochromocytoma ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-05854

Lanreotide for the Treatment of Metastatic or Unresectable ... This phase II trial studies the side effects of lanreotide and to see how well it works in treating patients with pheochromocytoma or paraganglioma.