Study on Natalizumab for Treating Recurrent or Resistant Lung Metastatic Osteosarcoma

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03811886

Provider View

This clinical trial is testing the safety and effectiveness of Natalizumab in children, adolescents, and young adults with lung metastatic osteosarcoma that has not responded to standard treatments.

Patient Parameters

Program Overview

The aim of this study is to see if Natalizumab, a drug currently approved for certain autoimmune disorders, can be safely and effectively used to treat children, adolescents, and young adults with lung metastatic osteosarcoma (pOS) that has returned, not responded, or progressed after standard treatments. The study will monitor the safety of the drug and how well it works in controlling the cancer and improving survival rates.

Description

This study involves a single group of participants who will all receive Natalizumab. It is designed to test the drug's safety and effectiveness in treating lung metastatic osteosarcoma (pOS) that cannot be surgically removed and has not responded to other treatments.

In the first phase, the study will gradually increase the dose of Natalizumab to find the safest and most effective dose. In the second phase, participants will continue treatment if their cancer shows improvement or remains stable after every three cycles, up to a maximum of 24 cycles, unless it is in their best interest to continue.

The study will include 3-9 participants in the first phase and 10-12 in the second phase. Participants will be monitored for side effects for 30 days after stopping treatment or until a specific reason defined in the study protocol occurs.

The goal is to determine if Natalizumab can be a safe and effective immunotherapy option for young patients with pOS. The study will assess the drug's safety, how well it works in treating the cancer, and its impact on overall survival.

Eligibility Criteria

Inclusion Criteria

  • Participants can be male or female, aged 5 to 30 years.
  • Must have a confirmed diagnosis of lung metastatic osteosarcoma (pOS).
  • Must have measurable lung or pleural disease that has progressed or not responded to standard treatments.
  • Must have recovered from previous treatment side effects, except for hair loss, loss of appetite, bone pain, and tumor pain.
  • Must have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 750/mcL.
    • Platelet count of at least 75,000/mcL without needing transfusions.
    • Hemoglobin level of at least 8.0 g/dL.
    • Normal liver function tests.
    • Heart function with an ejection fraction of at least 50%.
  • Must be able to understand and sign a consent form if 18 or older, or provide assent if under 18.

Exclusion Criteria

  • Have osteosarcoma outside the lungs or pleura.
  • Have ongoing treatment side effects greater than Grade 1, except for hair loss, loss of appetite, bone pain, and tumor pain.
  • Are receiving other investigational drugs.
  • Have a history of allergic reactions to Natalizumab or similar drugs.
  • Are on immunosuppressive therapy.
  • Have uncontrolled illnesses, such as active infections, liver failure, heart problems, or psychiatric conditions.
  • Are pregnant or breastfeeding.
  • Are HIV-positive or on antiretroviral therapy.
  • Have or have had progressive multifocal leukoencephalopathy (PML).
  • Have lung or pleural disease that can be completely removed by surgery.

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