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Alkylating agents

Chemotherapy +/− Temsirolimus for Muscle Cancer

Phase 3

Waitlist Available

Led By Abha A Gupta

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must be < 21 years of age at the time of enrollment for the Feasibility Phase

Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial tests if a combo of drugs can be more effective than just drugs alone in treating a type of muscle cancer.

Who is the study for?

This trial is for patients under 40 with newly diagnosed Rhabdomyosarcoma (RMS), a type of muscle tissue cancer, who haven't had previous chemotherapy or radiation. They must have an acceptable level of blood cells and kidney function, and be able to perform daily activities at least half the time. Pregnant women, breastfeeding mothers, those with uncontrolled diabetes or cholesterol levels, and individuals not using effective contraception are excluded.Check my eligibility

What is being tested?

The study compares standard combination chemotherapy (including vincristine sulfate, dactinomycin, cyclophosphamide) alternated with other drugs like irinotecan hydrochloride or vinorelbine against the same chemotherapy plus temsirolimus. The goal is to see if adding temsirolimus better stops RMS from growing by blocking enzymes needed for cell growth.See study design

What are the potential side effects?

Chemotherapy can cause side effects such as nausea, hair loss, fatigue, increased risk of infection due to low blood counts. Temsirolimus may add risks like mouth sores, rash, high blood sugar levels and lung problems. Each patient's experience can vary.

Eligibility Criteria

Inclusion Criteria

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

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I am under 21 years old.

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My kidney function is normal or near normal.

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My bilirubin levels are within the normal range for my age.

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I have enough tissue samples for the study.

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I can do most activities but need help with some, regardless of my age.

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I am 40 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years 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 (EFS)

Secondary outcome measures

Overall survival (OS)

Other outcome measures

Frequency of circulating tumor DNA (ctDNA) at diagnosis and subsequent time-points

Glucose

Patient outcome based on their forkhead box O1 protein (FOXO1) partner, by evaluating PAX3 vs. PAX7 in all patients found to be FOXO1 fusion positive

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Regimen C (FOXO1 fusion negative, VAC/VA)Experimental Treatment6 Interventions

Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Regimen B (VAC/VI/temsirolimus)Experimental Treatment9 Interventions

Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.

Group III: Regimen A (VAC/VI)Experimental Treatment7 Interventions

Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinorelbine

2013

Completed Phase 4

~2190

Irinotecan Hydrochloride

2010

Completed Phase 3

~1940

Cyclophosphamide

1995

Completed Phase 3

~3770

Dactinomycin

2010

Completed Phase 3

~1310

Radiation Therapy

2017

Completed Phase 3

~7250

Vincristine Sulfate

2005

Completed Phase 3

~10150

Temsirolimus

2008

Completed Phase 2

~1940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,116 Total Patients Enrolled

87 Trials studying Rhabdomyosarcoma

11,520 Patients Enrolled for Rhabdomyosarcoma

Abha A GuptaPrincipal InvestigatorChildren's Oncology Group

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02567435 — Phase 3

Rhabdomyosarcoma Research Study Groups: Regimen A (VAC/VI), Regimen B (VAC/VI/temsirolimus), Regimen C (FOXO1 fusion negative, VAC/VA)

Rhabdomyosarcoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02567435 — Phase 3

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02567435 — Phase 3

Frequently Asked Questions

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

What conditions does Regimen A (VAC/VI) intend to alleviate?

"Regimen A (VAC/VI) is an effective course of treatment for lymphoma, acute lymphoblastic leukemia and oral pain."

Answered by AI

Has the federal government sanctioned the VAC/VI Regimen A protocol?

"There is prior clinical data endorsing the safety of Regimen A (VAC/VI), so it obtained a score of 3."

Answered by AI

Is this experiment currently open for sign-up?

"Contrary to the information posted on clinicaltrials.gov, this research project is currently not recruiting participants. The study was initially listed in May of 2016, but has been amended most recently in April 2023 - with no current plans for recruitment. Nevertheless, 1281 other studies are still taking partakers at present time."

Answered by AI

How many establishments are involved in the management of this research?

"Lakeland Medical Center Saint Joseph in Saint Joseph, Michigan, Kaiser Permanente-Bellflower in Bellflower, California and Golisano Children's Hospital of Southwest Florida in Fort Myers, Florida are the main sites for this trial. However there also exists 296 auxiliary locations which help contribute to its success."

Answered by AI

What is the total number of participants involved in this research endeavor?

"No longer accepting any more participants, this trial has been in effect since May 23rd 2016 and was last edited on April 1st 2023. If you are interested in other studies, there are presently 67 trials recruiting for alveolar rhabdomyosarcoma and 1214 seeking volunteers for Regimen A (VAC/VI)."

Answered by AI

Have any other investigations incorporated the VAC/VI Regimen A protocol?

"Regimen A (VAC/VI) was first explored in 1999 at Cancer Center and Beckman Research Institute, City of Hope. To date, 3046 studies have been completed. Currently there are 1214 ongoing trials with many based out of Saint Joseph, Michigan."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma

2016. "Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02567435.

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