Chemotherapy + Targeted Radiation for Brain Tumor

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: St. Jude Children's Research Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important part of the two clinical trials which resulted in the best survival results for children less than 3 years of age with medulloblastoma. Most patients treated on this trial will also receive radiation which is carefully targeted to the area of the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in fewer problems with thinking and learning than radiation to the whole brain and spinal cord. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.

Research Team

Amar Gajjar, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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).

Inclusion Criteria

WBC > 2,000/mm3

ANC > 500/mm3

Serum creatinine < 3 times upper limit of normal (ULN)

Exclusion Criteria

Living outside the US

I have had a condition where my lymphocytes multiply unusually.

I haven't had any cancer, except for skin cancer, in the last 5 years.

Treatment Details

Interventions

• Focal Conformal or Proton Beam Radiotherapy (Proton Beam Therapy)
• High-Risk Therapy (Chemotherapy)
• Induction Chemotherapy (Chemotherapy)
• Intermediate-Risk Therapy (Chemotherapy)
• Low-Risk Therapy (Chemotherapy)
• Methotrexate (Anti-metabolites)

Trial Overview 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.

Participant Groups

Group I: Low-Risk Patients Experimental Treatment 2 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 Therapy Experimental Treatment 2 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 Patients Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Dr. James R. Downing

St. Jude Children's Research Hospital

Chief Executive Officer since 2014

MD from University of Michigan Medical School

Dr. Ellis J. Neufeld

St. Jude Children's Research Hospital

Chief Medical Officer since 2017

MD, PhD from Harvard Medical School

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

The Pew Charitable Trusts

Collaborator

Trials

4

Recruited

3,100+