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Alkylating agents

Combination Chemotherapy for Rhabdomyosarcoma

Phase 3

Recruiting

Led By Wendy Allen-Rhoades

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender criteria

Patients must be =< 50 years of age at the time of enrollment

Must not have

Patients with central nervous system involvement of RMS

Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from study enrollment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new cancer treatment for patients with high risk rhabdomyosarcoma. The treatment is a combination of 4 drugs, and the trial will test if it is more effective than the current standard of care.

Who is the study for?

This trial is for patients up to 50 years old with high-risk rhabdomyosarcoma (RMS), including embryonal and alveolar types, but not adult-type pleomorphic. Eligible participants must have newly diagnosed RMS, meet specific stage and group criteria, have a certain kidney function level, normal bilirubin levels unless obstructed by tumor, and provide informed consent. Pregnant or breastfeeding women are excluded as well as those with uncontrolled infections or central nervous system involvement of RMS.

What is being tested?

The study tests the addition of vinorelbine to standard chemotherapy (vincristine, dactinomycin, cyclophosphamide) in treating high-risk RMS. It also examines maintenance therapy post-chemotherapy to see if it helps eliminate cancer or prevent its return. The medications used aim to stop cancer cell growth by damaging their DNA.

What are the potential side effects?

Chemotherapy drugs like vinorelbine can cause side effects such as nausea, hair loss, fatigue, low blood counts leading to infection risk or bleeding problems; vincristine may cause nerve damage; dactinomycin might lead to mouth sores; cyclophosphamide could result in bladder irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or near normal.

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I am 50 years old or younger.

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My bilirubin levels are within the normal range for my age.

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My cancer has spread to my bone marrow, confirmed by specific staining tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I have not had chemotherapy or radiation for RMS before joining.

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I do not have any untreated infections.

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My RMS is a second cancer, previously treated with chemo or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival

Secondary study objectives

Feasibility and safety assessed by the adverse events, toxicities and treatment delays

Incidence of adverse events

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (vinorelbine, VAC, VINO-CPO)Experimental Treatment13 Interventions

Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8, vincristine sulfate IV on day 15, dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5 and 8-14, and cyclophosphamide IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40. MAINTENANCE: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15, and cyclophosphamide PO on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms undergo CT, MRI, PET, x-ray imaging, and/or bone scan, as well as blood sample collection throughout the trial. Patients may also undergo bone marrow aspiration and/or biopsy as clinically indicated.

Group II: Arm A (VAC, VINO-CPO)Experimental Treatment13 Interventions

Patients receive vincristine sulfate IV on days 1, 8 and 15 of cycles 1-4, 7, 8, 11, and 12, and day 1 of cycles 5, 6, 9, 10, 13, and 14. Patients also receive dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5, 8-10, and 11-14, and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy on weeks 13 and 40. MAINTENANCE: Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1, 8, and 15, and cyclophosphamide PO on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms undergo CT, MRI, PET, x-ray imaging, and/or bone scan, as well as blood sample collection throughout the trial. Patients may also undergo bone marrow aspiration and/or biopsy as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Dactinomycin

2010

Completed Phase 3

~1310