Study on Maintenance Pazopanib, Radiation Therapy, and Selinexor for Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06239272

Provider View

This clinical trial is exploring a new treatment approach for patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). The study aims to evaluate the effectiveness and safety of combining different therapies, including maintenance pazopanib, radiation therapy, and selinexor, based on the risk level of the disease.

Patient Parameters

Program Overview

The study is designed for patients diagnosed with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). It aims to test how well different combinations of treatments work for patients with varying levels of risk. For those with intermediate risk, the study will look at how well the combination of ifosfamide, doxorubicin, pazopanib, and surgery, with or without radiation therapy, works over three years. For high-risk patients, the study will determine the best dose of selinexor when combined with other treatments. The study will also explore how these treatments affect the body and their potential side effects.

Description

This study is focused on finding the best treatment combinations for patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). It involves different groups based on the risk level of the disease:

  • Intermediate-Risk Group: The study will test if a combination of drugs (ifosfamide, doxorubicin, pazopanib) and surgery, with or without radiation, can improve survival rates over three years. It will also study how these drugs work in the body and their side effects.

  • High-Risk Group: The study will find the safest and most effective dose of selinexor when used with other treatments. It will also look at how these drugs work together and their side effects.

The study will also explore the overall survival rates, the safety of the treatments, and how well the cancer responds to the treatment. Researchers will look at the effects of radiation therapy and how it impacts nearby healthy tissues. They will also study the genetic makeup of the tumors to understand how it affects treatment outcomes.

Participants will undergo various tests and procedures to monitor their health and the effectiveness of the treatment. The study aims to provide valuable insights into the best treatment strategies for NRSTS.

Eligibility Criteria

Inclusion Criteria

  • Must be 30 years old or younger at the time of diagnosis.
  • Must have had surgery to remove the tumor or be able to start treatment within 28 days after surgery.
  • Must be in good overall health, with a performance status score of 60 or higher.
  • Must have a specific type of sarcoma (CIC-DUX4 rearranged) for high-risk group.
  • Must have adequate organ function, including kidneys, liver, heart, and lungs.
  • Must have good bone marrow function, with specific blood cell counts.
  • Must not have received any prior treatment for NRSTS.
  • Must not have any other serious medical conditions that could affect participation.
  • Must agree to use effective birth control during the study and for a period after treatment.

Exclusion Criteria

  • Cannot have primary CNS sarcoma or metastases in the brain.
  • Cannot have certain types of tumors, such as malignant rhabdoid tumor or rhabdomyosarcoma.
  • Cannot have uncontrolled high blood pressure or bleeding disorders.
  • Cannot have received prior treatments like chemotherapy or radiation for NRSTS.
  • Cannot be taking certain medications that affect the study drugs.
  • Cannot have conditions that affect the absorption of oral medications.
  • Cannot have a history of serious wounds or fractures that are not healing.
  • Cannot be pregnant or breastfeeding, and must agree to use birth control if of childbearing potential.
  • Cannot have any other active infections or serious medical conditions that could interfere with the study.

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