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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)

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

Study 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).Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

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

Primary outcome measures

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 outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,306,284 Total Patients Enrolled

University of FloridaOTHER

1,340 Previous Clinical Trials

715,403 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,860 Total Patients Enrolled

Media Library

Focal Conformal or Proton Beam Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00602667 — Phase 2

Brain Tumor Research Study Groups: Intermediate-Risk Therapy, Low-Risk Patients, High-Risk Patients

Brain Tumor Clinical Trial 2023: Focal Conformal or Proton Beam Radiotherapy Highlights & Side Effects. Trial Name: NCT00602667 — Phase 2

Focal Conformal or Proton Beam Radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00602667 — Phase 2

Frequently Asked Questions

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

What other experiments have been conducted on High-Risk Therapy?

"City of Hope Comprehensive Cancer Center conducted the first High-Risk Therapy trial in 1997, and since then 3692 have been completed. Currently 2131 studies are active, with a large portion based out of Memphis Tennessee."

Answered by AI

In what circumstances is High-Risk Therapy commonly prescribed?

"High-Risk Therapy is employed for the management of leukemia, as well as other illnesses like prostate cancer, lung cancers and initial treatment."

Answered by AI

Are there a multitude of health care facilities conducting this investigation in North America?

"This experiment is seeking participants at St. Jude Children's Research Hospital in Memphis, Tennessee, the Children's Hospitals and Clinics of Minnesota - St. Paul in Saint Paul, and Rady Children's Hospital in San Diego as well as 5 other sites across the nation."

Answered by AI

Has the FDA approved any methods of High-Risk Therapy?

"There is limited data available to confirm the safety of High-Risk Therapy, so it has a score of 2. This is due to this medical trial being Phase 2, which means there are only some sources that support its security but none affirming its efficacy."

Answered by AI

Are there any vacancies still available for enrolment in this research?

"At present, this clinical trial is no longer searching for suitable candidates. It was initially posted on December 17th 2007 and last updated on December 2nd 2021. Should you wish to be a part of other trials that are actively recruiting, there are 454 studies available for glioma research and an additional 2131 medical investigations concerning High-Risk Therapy open for enrollment."

Answered by AI

How many individuals are taking part in this research?

"This research initiative is no longer enrolling patients. It was initially created on December 17th, 2007 and last amended on December 2nd 2021. If you seek other clinical trials, the current tally of actively admitting glioma patients stands at 454 while High-Risk Therapy has upwards of 2131 studies recruiting participants."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Risk-adapted Therapy for Young Children with Medulloblastoma (SJYC07): Therapeutic and Molecular Outcomes from a Multicentre, Phase 2 Trial

Robinson, Giles W, Vasilisa A Rudneva, Ivo Buchhalter, Catherine A Billups, Sebastian M Waszak, Kyle S Smith, Daniel C Bowers, et al.. 2018. “Risk-adapted Therapy for Young Children with Medulloblastoma (SJYC07): Therapeutic and Molecular Outcomes from a Multicentre, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30204-3.

Journal of Clinical OncologyJournal

Clinical Outcomes and Patient-matched Molecular Composition of Relapsed Medulloblastoma

Kumar, Rahul, Kyle S. Smith, Maximilian Deng, Colt Terhune, Giles W. Robinson, Brent A. Orr, Anthony P. Y. Liu, et al.. 2021. “Clinical Outcomes and Patient-matched Molecular Composition of Relapsed Medulloblastoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01359.

Journal of Clinical OncologyJournal

Predictors of Cognitive Performance Among Infants Treated for Brain Tumors: Findings from a Multisite, Prospective, Longitudinal Trial

Ali, Jeanelle S., Jason M. Ashford, Michelle A. Swain, Lana L. Harder, Bonnie L. Carlson-Green, Jonathan M. Miller, Joanna Wallace, et al.. 2021. “Predictors of Cognitive Performance Among Infants Treated for Brain Tumors: Findings from a Multisite, Prospective, Longitudinal Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01687.

clinicaltrials.govStudy