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Chemotherapy

Multimodal Therapy for Rhabdomyosarcoma

Phase 2

Waitlist Available

Led By Matthew J. Krasin, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Initiation of chemotherapy is planned within 6 weeks of the definitive biopsy or surgical resection

Adequate bone marrow function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after last low or intermediate risk arm enrollment

Awards & highlights

Study Summary

This trial will treat people with newly diagnosed rhabdomyosarcoma with different intensities of chemotherapy, radiation and surgery based on how high-risk the cancer is. For the intermediate and high risk patients, they will receive an additional 12 weeks of maintenance therapy with anti-angiogenic chemotherapy.

Who is the study for?

This trial is for children and young adults under 22 with newly diagnosed rhabdomyosarcoma (RMS), a type of muscle cancer. They must have low, intermediate, or high-risk disease levels, be able to start chemotherapy within 6 weeks after diagnosis, and have good organ function. Pregnant or breastfeeding individuals can't join.Check my eligibility

What is being tested?

The study tests risk-adapted therapy using standard/intensified chemo, radiation, surgery for RMS patients. It aims to improve survival rates in intermediate/high-risk groups by adding maintenance anti-angiogenic therapy after initial treatment.See study design

What are the potential side effects?

Possible side effects include those from chemotherapy like nausea, hair loss, blood disorders; surgical complications; radiation-related skin issues; and specific toxicities from proton beam therapy such as damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

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

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I am starting chemotherapy within 6 weeks after my biopsy or surgery.

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My bone marrow is working well.

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I need emergency radiation therapy.

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I do not have any ongoing, untreated infections.

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I have been recently diagnosed with localized rhabdomyosarcoma.

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I can take care of myself and perform daily activities.

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I am younger than 22 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after last enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after last enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after last enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free survival (intermediate risk arm)

Secondary outcome measures

Event-free survival (high risk arm)

Incidence of CTC grade 3 and higher toxicities related to proton bream therapy (low and intermediate and high risk arms)

Local failure rate (high risk arm)

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Low-Risk, Subset 2Experimental Treatment7 Interventions

Lymph node sampling will take place pretreatment and pre-surgery. Participants receive 12 weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide). The tumor is evaluated to determine how it responded to treatment. Radiation therapy and/or surgical resection is performed to destroy or remove the remaining tumor. Twelve additional weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide) is given, followed by evaluation for tumor response. If delayed for medical reasons, radiation therapy and/or surgical resection is done at this time. Participants then receive 16 weeks of additional chemotherapy (vincristine, dactinomycin and cyclophosphamide). No further treatment is given, and participants are observed closely. Myeloid growth factor will be given if needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Group II: Low-Risk, Subset 1Experimental Treatment8 Interventions

Lymph node sampling will take place pretreatment and pre-surgery. Participants receive 12 weeks of chemotherapy (vincristine, dactinomycin and cyclophosphamide). They are then evaluated to determine how the tumor responded to treatment. Twelve additional weeks of chemotherapy (vincristine and dactinomycin) is given, followed by evaluation for tumor response. No further treatment is given, and participants are observed closely. Myeloid growth factor is given if needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Group III: Intermediate-RiskExperimental Treatment10 Interventions

Lymph node sampling takes place pretreatment and pre-surgery. Participants receive 12 weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide). The tumor is evaluated for treatment response. Radiation therapy and/or surgical resection is done. Twelve weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide) is followed by evaluation for tumor response. If delayed for medical reasons, radiation therapy and/or surgical resection is done at this time. Participants receive 16 weeks of chemotherapy (vincristine, dactinomycin, cyclophosphamide) followed by 12 weeks of maintenance treatment (bevacizumab, sorafenib, oral cyclophosphamide). No further treatment is given, and participants are observed closely. Myeloid growth factor is given if needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Group IV: High-RiskExperimental Treatment16 Interventions

Lymph node sampling takes place pretreatment and pre-surgery. Participants receive 6 weeks (2 cycles) chemotherapy (vincristine and irinotecan). The tumor is evaluated for treatment response. 3 cycles of chemotherapy [vincristine, doxorubicin, cyclophosphamide/ifosfamide, etoposide (or etoposide phosphate) (VDC/IE)] are given. Dexrazoxane is given prior to each dose of doxorubicin. Radiation therapy begins at week 4 or 20 (depending on tumor location) while receiving vincristine and irinotecan. 2 cycles of VDC/IE, 4 cycles of modified vincristine, dactinomycin, cyclophosphamide (VAC), then 2 cycles of modified vincristine/irinotecan (total of 54 weeks). High risk participants also receive additional maintenance therapy beginning week 55 with anti-angiogenic chemotherapy (bevacizumab, sorafenib, cyclophosphamide). Myeloid growth factor is given as needed. Participants also receive ^1^1C-methionine as described in the intervention section.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 3

~1020

Dactinomycin

2010

Completed Phase 3

~1310

Dexrazoxane

2016

Completed Phase 2

~80

Cyclophosphamide

1995

Completed Phase 3

~3780

Bevacizumab

2013

Completed Phase 4

~5280

Sorafenib

2014

Completed Phase 3

~1670

Vincristine

2003

Completed Phase 4

~2910

Surgical Resection

2018

Completed Phase 2

~420

Etoposide Phosphate

2011

Completed Phase 2

~160

Doxorubicin

2012

Completed Phase 3

~7940

Irinotecan

2017

Completed Phase 4

~2680

Ifosfamide

2010

Completed Phase 4

~2980

Etoposide

2010

Completed Phase 3

~2440

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,306,479 Total Patients Enrolled

14 Trials studying Rhabdomyosarcoma

4,412 Patients Enrolled for Rhabdomyosarcoma

Matthew J. Krasin, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01871766 — Phase 2

Rhabdomyosarcoma Research Study Groups: High-Risk, Intermediate-Risk, Low-Risk, Subset 1, Low-Risk, Subset 2

Rhabdomyosarcoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01871766 — Phase 2

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01871766 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the most popular reasons why doctors prescribe Radiation?

"While radiation is most commonly used to treat merkel cell cancer, it can also help patients with conditions like recurrent cervical cancer, amino acid supplementation therapy, and leukemia."

Answered by AI

Have similar studies been conducted previously?

"Alfacell sponsored the first ever clinical trial for radiation back in 1997 and, since then, this research has grown exponentially. There are now 1869 active trials in 79 countries spanning 3247 cities."

Answered by AI

Are there any participant vacancies in this clinical trial?

"Presently, this clinical trial is not recruiting patients. It was initially posted on December 4th, 2013 and last edited on July 5th, 2022. If you are looking for similar studies, 67 trials for rhabdomyosarcoma and 1869 radiation studies are currently enrolling participants."

Answered by AI

How many individuals are allowed to enroll in this clinical trial?

"This study is not recruiting at this time. According to the data on clinicaltrials.gov, it was posted on December 4th, 2013 and last updated July 5th, 2022. There are currently 67 other trials for rhabdomyosarcoma and 1869 radiation trials recruiting patients if you are looking for more options."

Answered by AI

What does the FDA have to say about Radiation as a treatment method?

"While there is some evidence that radiation is safe, it received a score of 2 because this is only supported by data from Phase 2 trials. There is currently no information regarding efficacy."

Answered by AI

Are there other case studies that have used Radiation as a treatment?

"The first documented use of radiation in a hospital setting was at Spectrum Health Hospital - Butterworth Campus in 1997. In the intervening years, 3821 clinical trials have been completed with 1869 currently active. A significant proportion of these ongoing trials are based out of Fort Worth, Texas."

Answered by AI

Recent research and studies

Developmental CellJournal

The Myogenesis Program Drives Clonal Selection and Drug Resistance in Rhabdomyosarcoma

Patel, Anand G., Xiang Chen, Xin Huang, Michael R. Clay, Natalia Komorova, Matthew J. Krasin, Alberto Pappo, et al.. 2022. “The Myogenesis Program Drives Clonal Selection and Drug Resistance in Rhabdomyosarcoma”. Developmental Cell. Elsevier BV. doi:10.1016/j.devcel.2022.04.003.

clinicaltrials.govStudy

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

2013. "Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01871766.

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