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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

Pivotal Trial

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

Pivotal Trial

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

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

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

Methotrexate

FDA approved

peripheral blood stem cell transplantation

1997

Completed Phase 3

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