A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)

Conditions

• Rhabdomyosarcoma

Eligibility Criteria

Sex

ALL

Age

N/A - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and cerebrospinal fluid sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Bone Scan — PROCEDURE
  Undergo bone scan
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Cyclophosphamide — DRUG
  Given IV and PO
• Dactinomycin — BIOLOGICAL
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Lymph Node Biopsy — PROCEDURE
  Undergo lymph node biopsy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo FDG PET scan
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Resection — PROCEDURE
  Undergo resection surgery
• Survey Administration — OTHER
  Ancillary studies
• Vincristine Sulfate — DRUG
  Given IV
• Vinorelbine Tartrate — DRUG
  Given IV

Study Details

This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.

Key Dates

First listed

Mar 12, 2026

Start date

Jul 14, 2026

Status verified

Aug 2026

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

342 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regimen A (Higher cyclophosphamide dose regimen
  See Detailed Description for Regimen A.
• Experimental: Regimen B (Lower cyclophosphamide dose, maintenance)
  See Detailed Description for Regimen B.

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: From randomization until the first occurrence of progression or relapse, second malignancy, or death, assessed up to 5 years ]

Locations (86)

Find similar trials in Birmingham, AL

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