← Back to Search

Chemotherapy

High-Dose Consolidation Chemotherapy for Medulloblastoma

Q: In what cases is Induction generally employed therapeutically?

<p><a href="https://www.withpower.com/clinical-trials/merkel-cell-carcinoma">Merkel cell carcinoma</a>, <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, and initial treatment can <a href="https://www.withpower.com/clinical-trials/all">all</a> benefit from induction therapy.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I have a specific type of brain tumor.

Select...

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

Select...

My liver functions are within the required range.

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

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

Primary outcome measures

Compare tandem consolidation vs. single cycle consolidation A

Compare tandem consolidation vs. single cycle consolidation B

Secondary outcome measures

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

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's of AlabamaOTHER

8 Previous Clinical Trials

2,725 Total Patients Enrolled

Parth PatelLead Sponsor

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,253 Total Patients Enrolled

1 Trials studying Medulloblastoma

120 Patients Enrolled for Medulloblastoma

Media Library

Induction (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02875314 — Phase 4

Medulloblastoma Research Study Groups: Tandem 3 Cycle Intensive Chemotherapy, Single Cycle Intensive Chemotherapy, Induction

Medulloblastoma Clinical Trial 2023: Induction Highlights & Side Effects. Trial Name: NCT02875314 — Phase 4

Induction (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02875314 — Phase 4

Frequently Asked Questions

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

In what cases is Induction generally employed therapeutically?

"Merkel cell carcinoma, leukemia, and initial treatment can all benefit from induction therapy."

Answered by AI

How widely is this project being implemented in the urban area?

"At this point in time, 60 different clinics are enrolling patients into the study. In particular, Orlando, Hamilton and Hempstead have trial sites available to those interested. To lessen travel demands during participation, it is recommended that you select the closest enrolment centre."

Answered by AI

What is the primary objective of this experimental endeavor?

"This clinical trial will span a period of 5 years and measure the efficacy of tandem consolidation versus single cycle consolidation as its primary outcome. Secondary objectives include evaluating the long-term neuropsychological effects using age-based tests and questionnaires, assessing prevalence and severity of therapy-related hearing loss through distortion product otoacoustic emissions (DPOAE), as well as evaluating endocrine functions with serum free T4, TSH, cortisol, IGF and IGFBP3 laboratory tests."

Answered by AI

Has Induction been explored in any other research endeavors?

"The first trial to study induction was conducted at City of Hope Comprehensive Cancer Center back in 1997. Since then, 3360 completed tests have been done with 2081 current studies still underway; a significant number are being administrated out of Orlando, Florida."

Answered by AI

What adverse effects could be experienced from Induction?

"With Induction in a Phase 4 trial, the safety rating is evaluated as 3 due to its approval status."

Answered by AI

What is the current enrollment quota for this medical experiment?

"That is correct. The information hosted on clinicaltrials.gov shows that this study, which was first published on September 1st 2015, is actively searching for participants. A total of 250 individuals need to be recruited across 60 different sites."

Answered by AI

Are there any vacancies for participants in this clinical trial?

"According to clinicaltrials.gov, this research project is still recruiting participants. It was first announced on September 1st 2015 and the details were most recently modified on February 16th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

Parth Patel 2015. "HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02875314.

All > Nevada > Medulloblastoma