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Alkylating agents
Chemotherapy for Rhabdomyosarcoma
Phase 3
Recruiting
Led By Josephine H Haduong
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
Patients must be =< 21 years at the time of enrollment
Patients must have a Lansky (for patients =< 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of >= 50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is examining how well different types of chemotherapy work in treating patients with different levels of risk for RMS cancer.
Who is the study for?
This trial is for patients up to 21 years old with newly diagnosed very low-risk or low-risk rhabdomyosarcoma, a type of soft tissue cancer. They must have specific stages and groups of the disease, proper organ function, no prior cancer treatments except surgery, and not be on certain drugs that affect vincristine.Check my eligibility
What is being tested?
The study tests a chemotherapy regimen using vincristine and dactinomycin over 24 weeks for very low-risk patients. It also assesses standard chemo effectiveness in low-risk patients and intensifies therapy for those with DNA mutations to improve outcomes.See study design
What are the potential side effects?
Possible side effects include hair loss, nausea, vomiting, mouth sores from chemotherapy; potential nerve damage from vincristine; skin changes or fatigue due to radiation therapy; increased risk of infection; and blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or younger.
Select...
I can do most activities but need help with some, regardless of my age.
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I have been newly diagnosed with a specific type of muscle cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Failure free survival (FFS) for low risk patients
Failure free survival (FFS) for very low risk patients
Secondary outcome measures
Feasibility of central molecular risk stratification of patients assessed by the percentage of patients who have molecular testing results returned by 6 weeks
Overall survival (OS) for low risk patients
Overall survival (OS) for very low risk patients
Other outcome measures
Methylation array profile of patients with fusion negative, low-risk rhabdomyosarcoma
Trial Design
3Treatment groups
Experimental Treatment
Group I: Regimen VAC/VA (VL RMS)Experimental Treatment8 Interventions
Patients with LR RMS receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 1-3. Patients also receive dactinomycin IV over 1-5 minutes or 10-15 minutes and cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 5-7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Radiation therapy (if needed) will be administered at cycle 5.Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Group II: Regimen VA (VLR RMS)Experimental Treatment6 Interventions
Patients with VLR RMS receive vincristine intravenously (IV) on day 1 of each cycle and days 8 and 15 of cycles 1, 3, 5, and 7 and dactinomycin IV over 1-5 minutes or over 10-15 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with MYOD1 or TP53 mutated tumors transition to Regimen M at cycle 2 (if mutation status is determined to be positive at week 3) or cycle 3 (if mutation status is determined to be positive after week 3). Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Group III: Regimen M (positive mutation)Experimental Treatment9 Interventions
Patients receive vincristine IV on day 1 of each cycle and days 8 and 15 of cycles 2-4, 7-8, and 11-12 and dactinomycin IV over 1-5 minutes or 10-15 minutes on day 1 of cycles 2-5 and 8-14. Patients also receive cyclophosphamide IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 12-13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo radiation therapy at cycle 5. Patients undergo CT scan, MRI, bone scan, PET scan and tumor biopsy throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2720
Dactinomycin
2010
Completed Phase 3
~1310
Radiation Therapy
2017
Completed Phase 3
~7250
Vincristine
2003
Completed Phase 4
~2910
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,735 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,868 Total Patients Enrolled
Josephine H HaduongPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had chemo or radiation for a non-cancer condition but will stop before starting the trial.I've had chemotherapy or radiation before for cancer, but surgery was only for removing it.My cancer's stage and group will be assessed.I am currently pregnant.I am 21 years old or younger.My kidney function tests are within the normal range.I can do most activities but need help with some, regardless of my age.I haven't taken any strong medication that affects liver enzymes in the last week.I cannot have radiation therapy if needed.My bilirubin levels are within the normal range for my age.I have been newly diagnosed with a specific type of muscle cancer.I have an infection that is not responding to treatment.My platelet count is at least 75,000 and I haven't needed a transfusion.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen VA (VLR RMS)
- Group 2: Regimen VAC/VA (VL RMS)
- Group 3: Regimen M (positive mutation)
Awards:
This trial has 2 awards, including:- 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.
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.
Has the FDA approved the use of radiation to treat patients?
"Radiation Therapy received a score of 3 because this is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Can you give us an estimate of how many hospitals are participating in this trial?
"There are 69 clinical trial sites enrolling patients for this study, some of which include Children's Hospital of The King's Daughters in Norfolk, Virginia, Mayo Clinic in Rochester in Rochester, Minnesota, and IWK Health Centre in Halifax, Nova Scotia."
Answered by AI
Can new patients still join the clinical trial?
"The most recent data from clinicaltrials.gov suggests that this trial is still looking for patients. The listing for the study was first posted on June 22, 2022 and updated October 21, 2022."
Answered by AI
How many people total are taking part in this experiment?
"In order to move this clinical trial forward, 205 patients that meet the pre-specified medical criteria are required to enroll. This research is being conducted at multiple locations, such as Children's Hospital of The King's Daughters in Norfolk, Virginia and Mayo Clinic in Rochester, Minnesota."
Answered by AI
What are the main goals that researchers hope to achieve with this clinical trial?
"The primary outcome of this study is failure-free survival (FFS) for low-risk patients. The study will evaluate FFS over a period of 5 years. Secondary outcomes include overall survival (OS) for very low-risk patients and low-risk patients. OS will be compared between patients with VLR rhabdomyosarcoma (RMS) treated with 24 weeks of vincristine, dactinomycin (VA) and patients from ARST0331 and D9602 with the same inclusion criteria. Feasibility of central molecular risk stratification of patients will also be assessed."
Answered by AI
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