Chemotherapy for Newly Diagnosed Very Low-Risk and Low-Risk Rhabdomyosarcoma

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05304585

Provider View

This study is testing a chemotherapy treatment plan for children and young adults with newly diagnosed very low-risk and low-risk rhabdomyosarcoma, a type of cancer that affects soft tissues. The goal is to maintain good outcomes while reducing treatment side effects.

Patient Parameters

Program Overview

Rhabdomyosarcoma is a cancer that forms in soft tissues. This study is testing a chemotherapy plan for patients with very low-risk and low-risk rhabdomyosarcoma. The aim is to keep good results while reducing treatment side effects. The study also looks at how patients with specific DNA changes in their cancer respond to different treatments. Patients will be divided into groups based on their cancer type and DNA changes to receive specific chemotherapy regimens.

Description

The main goals of this study are to see how well patients with very low-risk rhabdomyosarcoma (VLR-RMS) do when treated with 24 weeks of two chemotherapy drugs, vincristine and dactinomycin (VA), and to see how patients with low-risk rhabdomyosarcoma (LR-RMS) respond to a combination of three drugs, vincristine, dactinomycin, and cyclophosphamide (VAC), followed by VA.

The study also aims to understand the overall survival rates of these patients and to explore the use of a central system to classify the risk of rhabdomyosarcoma based on molecular features. Additionally, the study will collect blood and tissue samples for future research and examine the DNA profiles of patients with low-risk rhabdomyosarcoma.

Patients will be assigned to different treatment plans based on their cancer type and DNA changes. Those with specific DNA mutations will receive a more intensive treatment plan, called Regimen M.

  • Regimen VA: Patients with very low-risk rhabdomyosarcoma will receive vincristine and dactinomycin every 21 days for 8 cycles, unless the cancer progresses or side effects are too severe. If DNA mutations are found, patients will switch to Regimen M.

  • Regimen VAC/VA: Patients with low-risk rhabdomyosarcoma will receive vincristine, dactinomycin, and cyclophosphamide every 21 days for 4 cycles, followed by vincristine and dactinomycin for another 4 cycles. Radiation therapy may be added if needed. If DNA mutations are found, patients will switch to Regimen M.

  • Regimen M: Patients will receive vincristine, dactinomycin, and cyclophosphamide every 21 days for 12-13 cycles, with possible radiation therapy.

Throughout the study, patients will have various scans and tests to monitor their cancer and treatment response.

Eligibility Criteria

Inclusion Criteria

  • Must be enrolled in a related study (APEC14B1) and agree to participate in the Molecular Characterization Initiative.
  • Must be 21 years old or younger.
  • Must have a new diagnosis of specific types of rhabdomyosarcoma, including embryonal rhabdomyosarcoma (ERMS) and certain other subtypes.
  • Must meet specific criteria for cancer stage and clinical group.
  • Must have certain lymph node evaluations if the cancer is in specific body areas.
  • Must have a performance status score of 50 or higher, meaning they can perform daily activities with some limitations.
  • Must have adequate blood cell counts and organ function based on specific tests.
  • Must have normal liver function tests, unless affected by the tumor.
  • Must provide informed consent to participate.
  • Must meet all institutional and regulatory requirements for human studies.

Exclusion Criteria

  • Cannot have received prior chemotherapy or radiation for cancer.
  • Cannot have received certain medications that affect chemotherapy within 7 days before the study.
  • Cannot have uncontrolled infections.
  • Cannot be pregnant or breastfeeding.
  • Must agree to use effective birth control during the study if sexually active.

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