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Chemotherapy

High-Dose Consolidation Chemotherapy for Medulloblastoma

Phase 4

Waitlist Available

Led By Randal Olshefski, MD

Research Sponsored by Parth Patel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord)

Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord

Must not have

Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas)

Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether giving a higher dose of Consolidation (a cancer treatment) to high-risk patients with medulloblastoma will improve event-free survival (EFS) and overall survival (OS) without adding significant short-term or long-term side effects.

Who is the study for?

This trial is for children under 10 years old with high-risk medulloblastoma or other CNS embryonal tumors. They must not have had previous radiation or chemotherapy, except corticosteroids, and should have adequate organ function. Children over 10, with certain excluded diagnoses like AT/RT or ependymomas, are not eligible.

What is being tested?

The study tests whether a more intense chemotherapy regimen (tandem 3 cycles) improves survival without adding significant side effects compared to a single cycle of intensive chemo in young patients with specific brain tumors after completing 'Head Start 4' Induction.

What are the potential side effects?

While the trial description does not specify side effects, intensive chemotherapy can typically cause nausea, hair loss, increased infection risk due to low blood cell counts, fatigue, and may affect organ function.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with a brain or spinal cord tumor at age 10.

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I have been diagnosed with a specific brain or spinal cord tumor.

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My child was diagnosed with a specific brain tumor type before age 6 and we have the required tumor samples.

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My child was diagnosed with a specific brain tumor type between ages 6-10 and has enough tumor material for testing.

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I have a specific type of brain tumor.

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I will start chemotherapy within 28 days after my last surgery and 21 days after my latest brain and spine scans.

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My liver functions are within the required range.

Exclusion Criteria

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

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My cancer is not one of the excluded types listed for the study.

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My brain tumor has been biopsied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Compare tandem consolidation vs. single cycle consolidation A

Compare tandem consolidation vs. single cycle consolidation B

Secondary study objectives

Endocrine studies will be conducted using Serum-free T4, TSH, Cortisol, IGF and IGFBP3 laboratory tests.

Induction Cycle Reduction

Neuropathology Biorepository and Clinical Database

+6 more

Awards & Highlights

No Placebo-Only Group

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Tandem 3 Cycle Intensive ChemotherapyExperimental Treatment1 Intervention

The 2 drugs to be used in this treatment are thiotepa and carboplatin. These drugs will be given over 2 days to help kill the cancer cells. After 72 hours from getting these drugs, previously collected and frozen blood cells will be thawed and returned through the venous catheter. Day -4: Thiotepa, Carboplatin Day -3: Thiotepa, Carboplatin Day -2: Rest Day -1: Rest Day 0: Re-infusion of blood cells. Following recovery from the first cycle of this chemotherapy, about 28 days following the Day 0 reinfusion of blood cells, the same cycle will be repeated again. A total of 3 cycles of this therapy will be administered, over the course of 12 weeks.

Group II: Single Cycle Intensive ChemotherapyExperimental Treatment1 Intervention

The three drugs to be used in this research study are thiotepa, etoposide and carboplatin. These drugs will be given over 6 days to help kill the cancer cells. After 72 hours from getting these drugs, previously collected and frozen blood cells will be thawed and returned through the venous catheter. Carboplatin is given by vein over 4 hours. Thiotepa is given by vein over 3 hours. Etoposide is given by vein over 3 hours. The schedule for these drugs is as follows: Day -8: Carboplatin Day -7: Carboplatin Day -6: Carboplatin Day -5: Thiotepa, Etoposide Day -4: Thiotepa, Etoposide Day -3: Thiotepa, Etoposide Day -2: Rest Day -1: Rest Day 0: Re-infusion of blood cells

Group III: InductionExperimental Treatment1 Intervention

The 5 chemotherapy drugs used in the Induction part of treatment are vincristine, cisplatin, cyclophosphamide, etoposide and high-dose methotrexate. Three medications are also given to help reduce the side effects of the chemotherapy drugs. Filgrastim will be given through a vein or through a tiny needle into the tissue just under the skin to help blood counts recover after the chemotherapy. Mesna will be given through a vein with cyclophosphamide to help prevent bleeding in the bladder. Leucovorin will be given through a vein after the methotrexate to protect the body from the side effects of the methotrexate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Induction

2016

N/A

~240

0 / 9Eligibility criteria met