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Platinum-containing Compound

Chemotherapy +/− Etoposide for Brain Cancer

Phase 3
Waitlist Available
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed malignant brain tumor including specified subtypes
Age criteria for diagnosis and treatment eligibility
Must not have
Specific diagnoses or subtypes not allowed
Previously untreated disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing how effective chemotherapy is with or without etoposide in treating young patients with malignant brain tumors that haven't been treated before.

Who is the study for?
This trial is for young patients with untreated malignant brain tumors, including various types of gliomas and medulloblastoma. Participants must have proper liver function (bilirubin < 1.5 mg/dL) and kidney function (creatinine clearance ≥ 60 mL/min). They should not have had previous cancer treatments or surgery within the last 42 days, nor take dairy/grapefruit juice with temozolomide.
What is being tested?
The study tests if combination chemotherapy with or without etoposide followed by a stem cell transplant can effectively treat malignant brain tumors in children. It compares different chemo drugs and transplantation methods to see which works best at stopping tumor growth.
What are the potential side effects?
Chemotherapy may cause nausea, hair loss, fatigue, increased risk of infection due to low blood counts, mouth sores, and potential damage to organs like the heart or kidneys. Stem cell transplants carry risks such as graft failure or complications from immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is confirmed to be cancerous through testing.
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My age fits the trial's requirements for diagnosis and treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition does not match any excluded diagnoses or subtypes.
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My condition has not been treated before.
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I had major surgery less than 6 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Regimen D2Experimental Treatment12 Interventions
In courses 1, 3, and 5, patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 2 and 3, high-dose methotrexate IV over 4 hours on day 4, vincristine IV on days 1, 8, and 15 (in courses1 and 3), and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover. In courses 2 and 4, patients receive oral temozolomide once daily on days 1-5, oral etoposide once daily on days 1-10, cyclophosphamide IV over 1 hour on days 11 and 12, vincristine IV on days 1, 8, and 15 (in course 2), and G-CSF SC beginning on day 13 and continuing until blood counts recover. Patients receive consolidation therapy as in regimen C in combination with etoposide IV over 3 hours on days -5 to -3 and undergo autologous bone marrow or peripheral blood stem cell transplantation, receive G-CSF, and undergo radiotherapy as in regimen C.
Group II: Regimen CExperimental Treatment8 Interventions
Patients receive induction therapy of vincristine IV on days 1, 8, and 15 of courses 1-3, oral temozolomide once daily on days 1-5, and carboplatin IV over 4 hours on days 1 and 2. Patients also receive G-CSF SC beginning on day 6 and continuing until blood counts recover. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive consolidation therapy of carboplatin IV over 4 hours on days -8 to -6 and thiotepa IV over 3 hours on days -5 to -3, undergo reinfusion of bone marrow or peripheral blood stem cells on day 0, and receive G-CSF SC beginning on day 1 and continuing until blood counts recover. Beginning within 6 weeks after transplantation, some patients undergo radiotherapy once daily 5 days a week for 4-6 weeks in the absence of disease progression or unacceptable toxicity and some patients undergo radiotherapy if there is evidence of tumor remaining after completion of induction chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330
Methotrexate
FDA approved
Etoposide
FDA approved
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
Thiotepa
FDA approved
Cyclophosphamide
FDA approved
Vincristine
FDA approved
Cisplatin
FDA approved
Carboplatin
FDA approved
radiation therapy
1994
Completed Phase 3
~13390
autologous bone marrow transplantation
1997
Completed Phase 3
~3880

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
244 Previous Clinical Trials
5,072,946 Total Patients Enrolled
Kelley Haley, RN, BSNChildren's Hospital Los Angeles
Girish Dhall, MDChildren's Hospital Los Angeles
2 Previous Clinical Trials
280 Total Patients Enrolled

Media Library

Carboplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT00392886 — Phase 3
Brain Tumor Research Study Groups: Regimen C, Regimen D2
Brain Tumor Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00392886 — Phase 3
Carboplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00392886 — Phase 3
~6 spots leftby Sep 2025
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