A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

Summary

This phase III trial compares the safety and effect of adding vinorelbine to vincristine, dactinomycin, and cyclophosphamide (VAC) for the treatment of patients with high risk rhabdomyosarcoma (RMS). High risk refers to cancer that is likely to recur (come back) after treatment or spread to other parts of the body. This study will also examine if adding maintenance therapy after VAC therapy, with or without vinorelbine, will help get rid of the cancer and/or lower the chance that the cancer comes back. Vinorelbine and vincristine are in a class of medications called vinca alkaloids. They work by stopping cancer cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vinorelbine, vincristine, dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patient's life.

Conditions

• Alveolar Rhabdomyosarcoma
• Botryoid-Type Embryonal Rhabdomyosarcoma
• Embryonal Rhabdomyosarcoma
• Metastatic Embryonal Rhabdomyosarcoma
• Metastatic Rhabdomyosarcoma
• Solid Alveolar Rhabdomyosarcoma
• Spindle Cell Rhabdomyosarcoma
• Spindle Cell/Sclerosing Rhabdomyosarcoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV or PO

BIOLOGICAL

Dactinomycin

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Vincristine Sulfate

Given IV

DRUG

Vinorelbine Tartrate

Given IV

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Wendy Allen-Rhoades · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-14

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico
• Saudi Arabia

Study Locations