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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My brain tumor is confirmed to be cancerous through testing.
Select...
My age fits the trial's requirements for diagnosis and treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival at 2 years
Time to tumor progression, disease recurrence, or death of any cause
Toxicity
Secondary outcome measures
Overall survival
Response to induction as assessed by one-time tumor measurements at baseline and after completion of induction chemotherapy
Time to death
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
peripheral blood stem cell transplantation
1997
Completed Phase 3
~4330
Methotrexate
FDA approved
Temozolomide
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
232 Previous Clinical Trials
5,076,648 Total Patients Enrolled
Kelley Haley, RN, BSNChildren's Hospital Los Angeles
Girish Dhall, MDChildren's Hospital Los Angeles
1 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer fits the specific subtype criteria required.My last surgery was within the allowed time frame for this trial.My treatment plan is specific to my tumor type.My condition does not match any excluded diagnoses or subtypes.My condition has not been treated before.I had major surgery less than 6 weeks ago.My brain tumor is confirmed to be cancerous through testing.My age fits the trial's requirements for diagnosis and treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen C
- Group 2: Regimen D2
Awards:
This trial has 4 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purpose is temozolomide most often prescribed?
"Temozolomide is often used to treat merkel cell cancer. It can also be effective in leukemia, initial treatment, and prostate cancer cases."
Answered by AI
On how many different websites can I find information about this trial?
"Presently, the trial is being conducted in 32 different locations, with participating clinics situated in Los Angeles, Jacksonville and Orange among other cities. If you are considering enrolling in the study, it might be most convenient for you to choose a location nearest to you to reduce travel time commitments."
Answered by AI
Are we still able to accept participants for this experiment?
"This study is not recruiting at this time. The clinical trial was posted on March 1st, 2004 and last updated December 17th, 2013. If you are looking for other studies, there are 510 trials for nervous system neoplasms and 2331 temozolomide trials that are actively recruiting participants."
Answered by AI
Could you give an estimate for how many people are enrolled in this experiment?
"This study is not presently recruiting participants at this time. The clinical trial was initially posted on 3/1/2004 and was last edited on 12/17/2013. If you are searching for other studies, there are currently 510 studies actively enrolling participants with nervous system neoplasms and 2331 studies for temozolomide actively looking for participants."
Answered by AI
Has temozolomide passed government regulation for public consumption?
"Temozolomide received a safety score of 3 because it is a Phase 3 trial, meaning that there is both efficacy and safety data supporting its use."
Answered by AI
With what other drugs has temozolomide been tested in past clinical trials?
"The first clinical trial for temozolomide was completed in 1997 at City of Hope Comprehensive Cancer Center. As of now, there have been a total of 3659 completed trials and 2331 live trials. A large concentration of these active studies are based in Los Angeles, California."
Answered by AI
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