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Platinum-containing Compound

Chemotherapy + Stem Cell Transplant for Brain Cancer

Phase 3
Waitlist Available
Led By Claire M Mazewski
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior radiation therapy or chemotherapy other than corticosteroids
Children less than 8 months of age with M0 stage medulloblastoma eligible for study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up off-treatment up to 9 years
Awards & highlights

Summary

This trial is studying two different chemotherapy combinations to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma.

Who is the study for?
This trial is for young patients with newly diagnosed brain tumors, specifically supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma. They should have undergone recent surgery and meet specific health criteria like normal heart and lung function, adequate blood counts, and no prior chemo or radiation therapy.
What is being tested?
The study compares two chemotherapy regimens before intense chemotherapy followed by stem cell transplant to see which works better for treating these brain tumors. It includes drugs like Cisplatin, Methotrexate, Thiotepa, Carboplatin, Cyclophosphamide and others.
What are the potential side effects?
Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood counts. Stem cell transplantation may lead to complications including organ damage and graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had radiation or chemotherapy, only corticosteroids.
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My child is under 8 months old and has early-stage medulloblastoma.
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My diagnosis is a specific brain tumor called supratentorial PNET.
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My medulloblastoma is classic, not desmoplastic, and any remaining disease is smaller than 1.5 cm^2.
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My medulloblastoma is considered high-risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~off-treatment up to 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and off-treatment up to 9 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
Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate
Secondary study objectives
Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).
Number of Participants With Acute Hearing Loss and No Acute Hearing Loss
Central hypothyroidism
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (induction+consolidation chemotherapy, autologous PBSC)Experimental Treatment12 Interventions
Patients receive vincristine IV over 1 minute on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or PO every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses. Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (induction+consolidation chemotherapy, autologous PBSC)Active Control10 Interventions
Patients receive vincristine IV over 1 minute on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses. Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2960
Cyclophosphamide
2010
Completed Phase 4
~2320
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~2090
Leucovorin Calcium
2011
Completed Phase 3
~12500
Thiotepa
2008
Completed Phase 3
~2120
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~2360
Filgrastim
2000
Completed Phase 3
~3690
Methotrexate
2019
Completed Phase 4
~4400
Vincristine Sulfate
2005
Completed Phase 3
~10270

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,739 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,909 Total Patients Enrolled
Claire M MazewskiPrincipal InvestigatorChildren's Oncology Group

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT00336024 — Phase 3
Primitive Neuroectodermal Tumor Research Study Groups: Arm I (induction+consolidation chemotherapy, autologous PBSC), Arm II (induction+consolidation chemotherapy, autologous PBSC)
Primitive Neuroectodermal Tumor Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00336024 — Phase 3
Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00336024 — Phase 3
~5 spots leftby Sep 2025
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