Study on Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma and Adding Topotecan for Types II and III

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06647953

Provider View

This clinical trial is exploring the effectiveness of surgery combined with chemotherapy for treating Type I pleuropulmonary blastoma (PPB) and whether adding the drug topotecan to the usual treatment can improve outcomes for Types II and III PPB.

Patient Parameters

Program Overview

This study aims to find out how well surgery plus chemotherapy works compared to surgery alone for Type I pleuropulmonary blastoma (PPB). It also tests if adding the drug topotecan to the standard chemotherapy can improve treatment for Types II and III PPB. For Type I PPB, some children receive chemotherapy after surgery, but there is no standard rule for this. For Types II and III, the usual treatment involves several chemotherapy drugs. This study will see if adding topotecan can shrink the cancer better or reduce its spread with fewer side effects.

Description

The main goal of this study is to see how well children with Types II and III pleuropulmonary blastoma (PPB) respond to two cycles of a treatment that includes vincristine, topotecan, and cyclophosphamide. Researchers will also look at how long children with Types II and III PPB live without the cancer getting worse and their overall survival over three years. For Type I PPB, the study will compare outcomes for children treated with surgery alone versus surgery plus chemotherapy.

The study will also explore how often surgery can completely remove the tumor in children with Types I, II, and III PPB, and the complications that may arise from surgery. Researchers will collect tumor and blood samples to study the genetics of PPB and its impact on treatment outcomes.

Participants are divided into two groups based on their PPB type. In Group I, children under 5 with Type I PPB whose tumor couldn't be fully removed by surgery will receive chemotherapy. Others will be observed without chemotherapy. In Group II, children with Types II and III PPB will receive chemotherapy, and their response will determine further treatment steps. All participants will have regular scans and blood tests to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • 21 years old or younger.
  • Newly diagnosed with pleuropulmonary blastoma (PPB).
  • Eligible if diagnosed with Type I, Ir, II, or III PPB within 60 days before joining the study.
  • For Types II or III PPB, specific kidney function tests must be within normal limits based on age and sex.
  • For Types II or III PPB, liver function tests must be within specified limits.
  • Heart function must be adequate, with specific measurements from heart tests.
  • HIV-positive patients can participate if their viral load is undetectable and they are not on certain medications.

Exclusion Criteria

  • Have received prior chemotherapy specifically for PPB.
  • Have Charcot-Marie-Tooth disease.
  • Female patients who are pregnant or breastfeeding.
  • Sexually active patients who are not using effective birth control.
  • Must provide written informed consent to participate.
  • Must meet all institutional and regulatory requirements for human studies.

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