Study Summary
This trial will compare 4 different ways of giving chemotherapy to people newly diagnosed with a type of cancer called alveolar rhabdomyosarcoma.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: 5 years
5 years
Overall Survival
Baseline to 3 years
Adaptive Therapy Event Free Survival
First Strike Event Free Survival
Second Strike Event Free Survival
Baseline to 5 years
Treatment-related adverse events of a certain grade or higher
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Arm - D Conventional Therapy
1 of 4
Arm A - First Strike
1 of 4
Arm B - Second Strike - Maintenance
1 of 4
Arm C - Adaptive Therapy
1 of 4
Active Control
Experimental Treatment
28 Total Participants · 4 Treatment Groups
Primary Treatment: Vinorelbine · No Placebo Group · Phase 2
Arm A - First StrikeExperimental Group · 3 Interventions: Actinomycin D, Vinorelbine, Cyclophosphamide · Intervention Types: Drug, Drug, Drug
Arm B - Second Strike - MaintenanceExperimental Group · 5 Interventions: Actinomycin D, Vinorelbine, Vincristine, Cyclophosphamide Pill, Cyclophosphamide · Intervention Types: Drug, Drug, Drug, Drug, Drug
Arm C - Adaptive TherapyExperimental Group · 3 Interventions: Actinomycin D, Vincristine, Cyclophosphamide · Intervention Types: Drug, Drug, Drug
Arm - D Conventional TherapyActiveComparator Group · 3 Interventions: Actinomycin D, Vincristine, Cyclophosphamide · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinorelbine
FDA approved
Vincristine
FDA approved
Cyclophosphamide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
504 Previous Clinical Trials
125,985 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
72 Patients Enrolled for Rhabdomyosarcoma
National Pediatric Cancer FoundationOTHER
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
72 Patients Enrolled for Rhabdomyosarcoma
Damon Reed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Participants must have FISH, PCR or other molecular confirmation of PAX/FOXO1 fusion per institutional standards.
You must have sufficient tissue for correlative testing.
Patients with distant metastatic disease must have distant metastatic disease
You are a woman of childbearing potential.
You are a man who is sexually active with women of child bearing potential
You must be able to understand and sign a written informed consent or assent document.
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Conditions
Cancer Related
Treatments