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Proton Beam Therapy

Chemotherapy + Targeted Radiation for Brain Tumor

Phase 2

Waitlist Available

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

Histologically confirmed newly diagnosed CNS tumors including but not limited to Medulloblastoma, Supratentorial primitive neuroectodermal tumor (PNET), Pineoblastoma, Atypical teratoid rhabdoid tumor (ATRT), Choroid plexus carcinoma, High grade glioma, Ependymoma

Lansky performance status ≥ 30 (except for posterior fossa syndrome)

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of chemotherapy drugs to treat brain tumors in young children. The chemotherapy drugs in this study include the drug methotrexate. The trial will also give radiation therapy which is carefully targeted to the area of the tumor.

Who is the study for?

This trial is for young children with newly diagnosed brain tumors, including medulloblastoma and ependymoma. Eligible kids must have had recent surgery but no prior chemo or radiation, except steroids. They need to have certain blood cell counts within a healthy range and be under 3 years old at diagnosis (or under 5 for specific conditions).

What is being tested?

The study tests how well a mix of chemotherapy drugs works alongside targeted radiation therapy in treating brain tumors in kids. The goal is to delay radiation until the child's brain has developed more, potentially reducing cognitive side effects.

What are the potential side effects?

Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to lower blood cell counts. Radiation may lead to skin irritation at the treatment site and potential long-term impacts on growth and cognitive development.

Eligibility Criteria

Inclusion Criteria

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

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I have a newly diagnosed brain tumor, such as Medulloblastoma or Glioma.

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I can do some activities but need help, except if I have posterior fossa syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes multiply unusually.

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients

Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients

Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup

Secondary study objectives

4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1

4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2

4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy

+69 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low-Risk PatientsExperimental Treatment2 Interventions

Patients with GTR/M0 medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy. Note: Accrual to the low-risk medulloblastoma cohort is closed as of 12/2/2015. Accrual to the low-risk high grade glioma remains open.

Group II: Intermediate-Risk TherapyExperimental Treatment2 Interventions

Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.

Group III: High-Risk PatientsExperimental Treatment2 Interventions

Patients with CNS metastatic disease will receive induction chemotherapy and high-risk therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Induction Chemotherapy

2012

Completed Phase 2

~720

0 / 4Eligibility criteria met