High-Dose Consolidation Chemotherapy for Medulloblastoma

Palo Alto (17 mi)

Overseen byRandal Olshefski, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Parth Patel

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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

I have a specific type of brain tumor.

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

My liver functions are within the required range.

Exclusion Criteria

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

My brain tumor has been biopsied.

Treatment Details

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.

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.