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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ off-treatment up to 9 years

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

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

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

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~2090

Cyclophosphamide

2010

Completed Phase 4

~2310