Study on Treating Newly Diagnosed Rhabdomyosarcoma in Children Using Molecular Risk Stratification and Liposomal Irinotecan-Based Therapy

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06023641

Provider View

This clinical trial is testing a new treatment approach for children with newly diagnosed rhabdomyosarcoma, a type of cancer. The study aims to find the safest and most effective doses of a combination of chemotherapy drugs, including liposomal irinotecan, and to see how well they work when given with radiation therapy.

Patient Parameters

Program Overview

This study is exploring a new treatment for children with rhabdomyosarcoma, a type of cancer. It involves using a combination of chemotherapy drugs, including liposomal irinotecan, vincristine, and others, to treat children with intermediate and high-risk disease. The study will also look at how well these drugs work when combined with radiation therapy. The main goals are to find the safest doses and to see if the treatment can help prevent the cancer from coming back or spreading.

Description

This clinical trial is divided into two phases. In Phase I, researchers will determine the safest doses of a new combination of chemotherapy drugs for children with intermediate and high-risk rhabdomyosarcoma. This phase will involve up to 18 patients in each group to find the maximum tolerated dose. In Phase II, the study will focus on how effective the treatment is in preventing cancer from returning or spreading over two years. The study will also compare two different radiation doses to see which is more effective in controlling the cancer. The trial will end once all patients have been followed for two years after treatment. Researchers will also study how genetic differences in patients affect how they process the drugs and how this relates to treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Children newly diagnosed with rhabdomyosarcoma of any subtype, including embryonal, alveolar, spindle cell, and sclerosing types.
  • Must have low, intermediate, or high-risk disease based on specific medical criteria.
  • Age under 22 years old.
  • Good overall health with a performance status score of 0, 1, or 2.
  • No prior chemotherapy or radiation therapy for rhabdomyosarcoma, except in emergencies.
  • Chemotherapy planned to start within 6 weeks of diagnosis.
  • Adequate bone marrow, liver, and kidney function as determined by specific blood tests.
  • Good lung function with no breathing difficulties at rest.
  • No active, uncontrolled infections.
  • Willingness to sign informed consent by participants or their guardians.

Exclusion Criteria

  • Previous chemotherapy (except steroids) or full course radiation therapy at the primary cancer site.
  • History of lung disease requiring significant treatment.
  • Sexually active patients who are not using effective birth control.
  • Pregnant females or those planning to become pregnant.
  • Breastfeeding females.

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