293 Participants Needed

Chemotherapy + Targeted Radiation for Brain Tumor

Recruiting at 5 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, but it does mention that no prior chemotherapy or radiotherapy is allowed, except for corticosteroid therapy.

Is the combination of chemotherapy and targeted radiation generally safe for treating brain tumors?

The combination of chemotherapy with methotrexate and radiation can cause severe neurotoxicity (nerve damage), especially when high doses are used. However, lower doses of methotrexate are better tolerated, and combining it with radiation has shown to prolong survival in some cases, though it still carries risks of toxicity.12345

How is the treatment of Chemotherapy + Targeted Radiation for Brain Tumor different from other treatments?

This treatment combines chemotherapy with targeted radiation, using advanced techniques like Focal Conformal or Proton Beam Radiotherapy, which aim to precisely target the tumor while sparing healthy tissue. The use of methotrexate, a high-dose chemotherapy drug, is notable for its ability to penetrate the blood-brain barrier, potentially enhancing the effectiveness of the treatment for brain tumors.678910

What data supports the effectiveness of the treatment Focal Conformal or Proton Beam Radiotherapy combined with chemotherapy for brain tumors?

Research indicates that combining chemotherapy with radiotherapy can be effective for treating brain tumors, especially those with poor prognosis, although it may lead to severe side effects. Studies have shown that this combined approach can improve survival rates and control tumor progression in some patients.678911

Who Is on the Research Team?

AG

Amar Gajjar, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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)
See 8 more

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.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy including high-dose intravenous methotrexate

Approximately 4 months

Consolidation Chemotherapy

Participants receive consolidation therapy including cyclophosphamide and pharmacokinetically targeted topotecan

Approximately 2 months

Maintenance Chemotherapy

Participants receive oral maintenance therapy

Up to 1 year

Radiation Therapy

Focal irradiation is given to intermediate risk patients who have reached at least 12 months of age upon completion of induction

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 6 months for 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Focal Conformal or Proton Beam Radiotherapy
  • High-Risk Therapy
  • Induction Chemotherapy
  • Intermediate-Risk Therapy
  • Low-Risk Therapy
  • Methotrexate
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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Low-Risk PatientsExperimental Treatment2 Interventions
Group II: Intermediate-Risk TherapyExperimental Treatment2 Interventions
Group III: High-Risk PatientsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

University of Florida

Collaborator

Trials
1,428
Recruited
987,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

The Pew Charitable Trusts

Collaborator

Trials
4
Recruited
3,100+

Published Research Related to This Trial

Radiation oncologists are exploring various innovative approaches, such as interstitial implants and stereotactic radiosurgery, to enhance cure rates for primary brain tumors while aiming to reduce long-term side effects.
These new radiation techniques must be integrated into a comprehensive treatment plan that includes other therapies to effectively manage primary malignant brain tumors.
Improving radiotherapy for brain tumors.Woo, SY., Maor, MH.[2005]
Current treatments for brain tumors are often inadequate, leading to ongoing research into the use of concurrent chemotherapy and radiotherapy to improve patient outcomes.
Trials are exploring new agents that can effectively cross the blood-brain barrier and minimize overlapping toxicities, which may enhance the safety and efficacy of combined therapies for brain tumor patients.
Concurrent chemotherapy and radiotherapy in patients with brain tumors.Glantz, MJ., Kim, L., Choy, H., et al.[2005]
Radiation therapy is crucial for treating adult brain tumors, but its application is changing based on tumor type, with ongoing trials exploring how to enhance its effectiveness and minimize side effects.
For low-grade gliomas, researchers are focusing on identifying patients who can safely delay radiation until necessary, while in cases like meningioma, advanced techniques like radiosurgery are improving outcomes for patients with a good prognosis.
Radiation oncology in brain tumors: current approaches and clinical trials in progress.Chan, MD., Tatter, SB., Lesser, G., et al.[2022]

Citations

Improving radiotherapy for brain tumors. [2005]
Concurrent chemotherapy and radiotherapy in patients with brain tumors. [2005]
Radiation oncology in brain tumors: current approaches and clinical trials in progress. [2022]
Dose Escalated Radiation Therapy for Glioblastoma Multiforme: An International Systematic Review and Meta-Analysis of 22 Prospective Trials. [2021]
Synchronous radiochemotherapy in unfavorable brain tumors of children and young adults. [2019]
Brain stem necrosis after preradiation high-dose methotrexate. [2019]
Non-AIDS primary CNS lymphoma: first example of a durable response in a primary brain tumor using enhanced chemotherapy delivery without cognitive loss and without radiotherapy. [2013]
Combined immunochemotherapy with reduced whole-brain radiotherapy for newly diagnosed primary CNS lymphoma. [2022]
Long-term follow-up of high-dose methotrexate-based therapy with and without whole brain irradiation for newly diagnosed primary CNS lymphoma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Synergistic effect between intraneoplastic methotrexate and radiation on experimental intracerebral rat gliosarcoma. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Local DNA Repair Inhibition for Sustained Radiosensitization of High-Grade Gliomas. [2020]
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