Vinorelbine for Rhabdomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
RhabdomyosarcomaVinorelbine - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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

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

2 of 3
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.