RMS13: Chemotherapy, Surgery, and Radiation Therapy in Treating Patients with Newly Diagnosed, Localized Rhabdomyosarcoma

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low-, Intermediate- and High-Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Rhabdomyosarcoma (low-risk, intermediate-risk and high-risk)

Eligibility Overview:

  • Must have newly diagnosed rhabdomyosarcoma
  • Less than 22 years of age
  • Has not received previous treatment with chemotherapy or radiation therapy

Description

This study will enroll participants who have been diagnosed with a type of cancer called rhabdomyosarcoma (RMS). RMS is a type of cancer that occurs in the soft tissue of the body, such as in the muscles.

The standard treatment for RMS is a combination of chemotherapy (treatment with anti-cancer drugs), plus surgery and/or radiation therapy (the use of high energy X-rays to kill cancer cells). In this study, the participants will be assigned to one of three risk groups: low-risk, intermediate- risk, or high-risk.  The term “risk” refers to the chance of the tumor coming back after treatment. The risk will be determined by the tumor’s location, size, whether it has spread to the lymph nodes and whether it can be removed with surgery.

The doctors in this study want to find out the most effective treatment with the least amount of therapy that will still cure participants with low-risk rhabdomyosarcoma. They also want to know if adding maintenance chemotherapy will benefit participants with intermediate-risk or high-risk tumors by delaying or preventing recurrence of their tumors. There are three parts (phases) to this study: Screening, Treatment, and Follow-Up.

Goals for low-risk and intermediate-risk groups:

  • To find out if adding maintenance chemotherapy will benefit participants with intermediate-risk tumors
  • To find out if giving less chemotherapy in some low-risk participants and limited volume proton beam radiation, instead of standard photon beam radiation, will result in fewer side effects but still result in a high cure rate
  • To find out how many participants will have a recurrence of their tumor and type of tumor recurrence in participants who receive risk-adapted local therapy
  • To learn more about side effects of this treatment

Goals of the high-risk group:

  • To find out if adding maintenance chemotherapy will benefit participants with high-risk tumors
  • To find out how many participants will have a recurrence of their tumor and type of tumor recurrence in participants who receive risk-adapted local therapy
  • To learn more about the side effects of this treatment

Eligibility criteria, among others, include:

  • Must be newly diagnosed or previously untreated with localized Rhabdomyosarcoma (RMS)
  • Must have low-risk, intermediate-risk or high-risk disease (See protocol or eligibility checklist for specific definition of each group.)
  • Must be 22 years of age or younger (eligible until 22nd birthday)
  • Age ≥ 16 must have ECOG score of 0-2 OR < age 16 must have Lansky Performance Score ≥ 50.
  • Must have received no prior radiotherapy or chemotherapy (excluding steroids) Note: Prior biopsy, surgical resection, and lymph node sampling is allowed.
  • Initiation of chemotherapy is planned within six weeks (42 days) of the definitive biopsy or surgical resection
  • No evidence of active, uncontrolled infection

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Matthew Krasin, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.