Study on Lanreotide for Treating Advanced Pheochromocytoma and Paraganglioma (LAMPARA)

Sponsor: Antonio Fojo

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03946527

Provider View

This clinical trial is testing the effectiveness and safety of the drug lanreotide, given every four weeks, in patients with advanced or metastatic pheochromocytoma and paraganglioma. The study also examines how lanreotide affects certain biochemical markers in the body.

Patient Parameters

Program Overview

The study aims to find out if lanreotide can help control tumor growth in patients with advanced or metastatic pheochromocytoma and paraganglioma. Researchers will compare the tumor growth rate while patients are on lanreotide to the growth rate before starting the treatment. They will also look at overall survival, progression-free survival, and response rates, as well as changes in specific biochemical markers in the body.

Description

Lanreotide is a medication approved for certain neuroendocrine tumors. This study is exploring its potential benefits for patients with pheochromocytoma and paraganglioma, which are rare types of tumors. Due to the rarity of these conditions, a unique method is being used to assess the drug's effectiveness by comparing tumor growth rates before and during treatment with lanreotide. At least three tumor measurements are needed for this analysis.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must provide signed informed consent.
  • Must have a confirmed diagnosis of malignant pheochromocytoma or paraganglioma with evidence of metastases or that cannot be surgically removed.
  • Must show recent disease progression while not on therapy or on ineffective therapy.
  • Must have measurable disease with at least one tumor that can be measured by a CT scan.
  • Must have a positive somatostatin receptor status confirmed by a specific scan.
  • Must not have had prior treatment with certain related drugs.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a life expectancy of more than 12 weeks.
  • Must meet specific blood and organ function criteria.
  • Women must not be pregnant and must use effective contraception if of childbearing potential.
  • Men must use a barrier method of contraception if their partner is of childbearing potential.
  • Must be able to communicate and cooperate with the study team.

Exclusion Criteria

  • Known allergy to lanreotide or similar drugs.
  • Recent treatment with other investigational drugs or certain cancer therapies.
  • Uncontrolled diabetes or high blood pressure.
  • Severe kidney or liver impairment.
  • Uncontrolled heart disease.
  • Other serious medical conditions that could affect safety or study results.

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