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Alkylating agents

Liposomal Irinotecan-Based Therapy for Rhabdomyosarcoma

Phase 1 & 2

Recruiting

Led By Alberto Pappo, 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

No evidence of active, uncontrolled infection.

Must have either low-, intermediate-risk or high-risk disease, defined as:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial studies drug combinations and radiation doses to improve outcomes in kids with rhabdomyosarcoma.

Who is the study for?

Children and young adults under 22 with newly diagnosed rhabdomyosarcoma (RMS), including specific subtypes, who haven't had prior chemotherapy or radiation (except in emergencies). They must have proper kidney, liver, and bone marrow function, not be pregnant or breastfeeding, agree to use contraception if of reproductive potential, and have no severe lung disease.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of liposomal irinotecan combined with other cancer drugs like vincristine and cyclophosphamide. It's for patients with intermediate to high-risk RMS. The study will also look at how well these drug combinations work when given alongside different types of radiation therapy.See study design

What are the potential side effects?

Possible side effects include reactions from the infusion process itself; digestive issues such as nausea or diarrhea; blood-related problems like anemia; increased risk of infections due to weakened immune systems; fatigue; liver toxicity; hair loss from chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any ongoing, untreated infections.

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My condition is classified as low, intermediate, or high risk.

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My cancer is in the early stage and only in my eye area.

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My cancer is intermediate-risk and lacks MYOD1 and TP53 mutations.

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My cancer is a specific type without FOXO1 fusion and is in an early stage.

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My cancer is a specific type that tests positive for a FOXO1 gene change.

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My cancer is in an early to mid-stage and hasn't spread to lymph nodes.

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My cancer is high-risk due to MYOD1 or TP53 mutations.

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My cancer is FOXO1 fusion positive.

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I am younger than 22 years old.

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This criterion seems incomplete or unclear. Could you provide more context or clarify?

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I don't have trouble breathing at rest and my oxygen levels are good.

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I can take care of myself and perform daily activities.

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My urinary flow is normal after treatment for a blockage caused by a tumor.

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My condition is low-risk with negative TP53 and MYOD1.

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My cancer is a specific type without FOXO1 fusion.

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My cancer is at an advanced stage but has not severely affected my function.

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My cancer is at stage 4.

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I have been newly diagnosed with rhabdomyosarcoma.

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My kidney function is good based on tests.

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My kidney function, measured by creatinine levels, is within the normal range for my gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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)

Local recurrence rate (LRR)

Maximum tolerated doses (MTDs)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low -riskExperimental Treatment5 Interventions

The participant will receive 12 weeks (4 cycles) of VAC chemotherapy (vincristine, dactinomycin and cyclophosphamide) followed by 12 weeks (4 cycles) of VA chemotherapy (vincristine, dactinomycin). Each cycle of VAC/VA chemotherapy will last for 3 weeks, for a total of 12 weeks (VAC or VA will be given in Week 1 of each cycle and vincristine will be given Weeks 2 and 3). At week 12, the participant will have scans and tests to reevaluate your tumor's response to the treatment. After surgery and radiation, the participant will receive an additional 12 weeks (4 cycles) of the same chemotherapy without cyclophosphamide. Vincristine and dactinomycin, also called "VA". After 4 cycles of VA, The investigator will re-evaluate the tumor again at week 24 and the patient will not get any more chemotherapy, but will be closely watched for any signs of tumor recurrence.

Group II: Intermediate-riskExperimental Treatment8 Interventions

The purpose of this part of the study is to find out if adding a drug called liposomal irinotecan (also called Onivyde) to standard chemotherapy/radiation/surgery will result in better treatment outcomes for patients with intermediate and high risk rhabdomyosarcoma. The investigators also want to find the best radiation dose to give for intermediate and high risk patients who have large tumors (> 5 cm). The patient will receive 42 weeks of VAC chemotherapy (vincristine, actinomycin D/dactinomycin and cyclophosphamide) alternating with VLI chemotherapy (vincristine/liposomal irinotecan). The participant will also have surgery to remove the tumor and radiation therapy during this time. After this therapy is completed you will get an additional 6 months of maintenance chemotherapy with vinorelbine and oral (by mouth) cyclophosphamide.

Group III: High-riskExperimental Treatment9 Interventions

The purpose of this part of the study is to find out if adding a drug called liposomal irinotecan (also called Onivyde) to standard chemotherapy/radiation/surgery will result in better treatment outcomes for patients with high risk rhabdomyosarcoma. The investigator also want to find the best radiation dose to give for high risk patients who have large tumors (> 5 cm). The patient will receive 42 weeks of VAC chemotherapy (vincristine, actinomycin D/dactinomycin and cyclophosphamide) alternating with VLIT chemotherapy (vincristine/liposomal irinotecan/temozolomide). Also having surgery to remove the participants tumor and radiation therapy during this time. After this therapy is completed the patient will get an additional 6 months of maintenance chemotherapy with vinorelbine and oral (by mouth) cyclophosphamide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vincristine

2003

Completed Phase 4

~2910

Temozolomide

2010

Completed Phase 3

~1930

Dactinomycin

2010

Completed Phase 3

~1310

Surgical Resection

2018

Completed Phase 2

~420

Cyclophosphamide

1995

Completed Phase 3

~3770

Vinorelbine

2013

Completed Phase 4

~2190

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,513 Total Patients Enrolled

14 Trials studying Rhabdomyosarcoma

4,410 Patients Enrolled for Rhabdomyosarcoma

Alberto Pappo, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

3 Previous Clinical Trials

537 Total Patients Enrolled

Frequently Asked Questions

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

Are there any opportunities for enrollment in this investigation?

"Data from clinicaltrials.gov indicates that this research initiative is not currently seeking participants, although it was initially posted on September 1st 2023 and edited as recently as August 27th 2023. Fortunately, there are 68 other studies actively looking for subjects at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

2024. "Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023641.

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