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Anti-tumor antibiotic
Chemotherapy for Rhabdomyosarcoma
Phase 2
Recruiting
Led By Jonathan MEtts, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a new histologic diagnosis of rhabdomyosarcoma
Participants must have FISH, PCR or other molecular confirmation of PAX/FOXO1 fusion per institutional standards
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will compare 4 different ways of giving chemotherapy to people newly diagnosed with a type of cancer called alveolar rhabdomyosarcoma.
Who is the study for?
This trial is for individuals newly diagnosed with metastatic Fusion Positive Rhabdomyosarcoma. They must have tissue available for testing, no prior chemotherapy, and molecular confirmation of PAX/FOXO1 fusion. Participants need to agree to contraception use if applicable and be able to take oral medications if in Arm B. Pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The study tests four chemotherapy strategies on Rhabdomyosarcoma: a first strike therapy (Arm A), a maintenance therapy after initial treatment (Arm B), an adaptively timed therapy based on disease response (Arm C), and conventional chemotherapy (Arm D). Patients choose their treatment arm with their physician.See study design
What are the potential side effects?
Chemotherapy drugs like Actinomycin D, Cyclophosphamide, Vinorelbine, and Vincristine can cause side effects including nausea, hair loss, fatigue, increased risk of infection due to lowered blood cell counts, mouth sores, and potential damage to organs such as the heart or kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with rhabdomyosarcoma.
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My cancer has a confirmed PAX/FOXO1 fusion.
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I have not had chemotherapy before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adaptive Therapy Event Free Survival
First Strike Event Free Survival
Second Strike Event Free Survival
Secondary outcome measures
Overall Survival
Treatment-related adverse events of a certain grade or higher
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm C - Adaptive TherapyExperimental Treatment3 Interventions
Therapy with VAC that starts and stops based on response, adaptive timing of therapy, with a prolonged time to progression rather than complete remission goal
Group II: Arm B - Second Strike - MaintenanceExperimental Treatment5 Interventions
Participants will receive conventional doses of Vincristine/Actinomycin D/Cyclophosphamide (VAC) until complete response (CR) for 12-42 weeks and then switch to up to 2 years of vinorelbine/oral cyclophoshamide
Group III: Arm A - First StrikeExperimental Treatment3 Interventions
Participants will receive 42 weeks of conventional doses of vinorelbine, actinomycin D and cyclophosphamide
Group IV: Arm - D Conventional TherapyActive Control3 Interventions
Participants will receive a chemotherapy combination based on published trials. An example would be 42 weeks of VAC but may also include irinotecan, doxorubicin, ifosfamide, etoposide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
2003
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3770
Vinorelbine
2013
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,464 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
72 Patients Enrolled for Rhabdomyosarcoma
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
182 Total Patients Enrolled
1 Trials studying Rhabdomyosarcoma
72 Patients Enrolled for Rhabdomyosarcoma
Jonathan MEtts, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body, confirmed by tests.I have been newly diagnosed with rhabdomyosarcoma.I will use contraception for 4 months after my chemotherapy ends.I agree to use two forms of birth control or practice abstinence during and after treatment.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.My cancer has a confirmed PAX/FOXO1 fusion.My cancer has not spread only to nearby lymph nodes.I have not had chemotherapy before.I can provide enough tissue samples for testing.I (or my guardian) can understand and am willing to sign the consent form.I can take cyclophosphamide by mouth or through a feeding tube.I am not on any cancer treatment drugs, but I may be using alternative medicines like cannabis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C - Adaptive Therapy
- Group 2: Arm - D Conventional Therapy
- Group 3: Arm A - First Strike
- Group 4: Arm B - Second Strike - Maintenance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widespread is the implementation of this clinical trial within the state?
"At present, 17 medical centres are recruiting for this trial. These include the Children's Hospital of Colorado in Aurora, Primary Children's Medical Center/Utah in Salt Lake City and Cleveland Clinic in Cleveland. Additionally, other sites are available throughout the US."
Answered by AI
What is the traditional purpose of utilizing Vinorelbine?
"Vinorelbine is frequently prescribed to treat lymphocytic lymphomas, but it can also be utilized in the treatment of gestational trophoblastic disease and other neoplasms as well as chronic granulocytic leukemias."
Answered by AI
Are there any openings for patients to join this investigation?
"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical study is currently recruiting participants, having been posted on September 27th 2020 and last updated November 17th 2022. 28 patients must be enrolled from across 17 distinct locations."
Answered by AI
Has Vinorelbine been endorsed by the United States Food and Drug Administration?
"Vinorelbine's safety score was assigned a 2, given the presence of some evidence for its security and lack thereof when it comes to efficacy."
Answered by AI
Could you explain any other experiments involving Vinorelbine that have been conducted?
"At the moment, Vinorelbine is being investigated in 916 active clinical trials with 194 of those studies being conducted at Phase 3. While a majority of these trials occur in Philadelphia, there are 33151 other medical centres worldwide that have also initiated studies on this medication's efficacy."
Answered by AI
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