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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I haven't had radiation or chemotherapy, only corticosteroids.
Select...
My child is under 8 months old and has early-stage medulloblastoma.
Select...
My diagnosis is a specific brain tumor called supratentorial PNET.
Select...
My medulloblastoma is classic, not desmoplastic, and any remaining disease is smaller than 1.5 cm^2.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate
Secondary outcome measures
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 moreTrial 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
Leucovorin Calcium
2011
Completed Phase 3
~12290
Etoposide
2010
Completed Phase 3
~2440
Cyclophosphamide
1995
Completed Phase 3
~3780
Thiotepa
2008
Completed Phase 3
~2150
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Filgrastim
2000
Completed Phase 3
~3670
Methotrexate
2013
Completed Phase 4
~3800
Vincristine Sulfate
2005
Completed Phase 3
~10110
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,609 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,062 Total Patients Enrolled
Claire M MazewskiPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation or chemotherapy, only corticosteroids.My breathing and oxygen levels are stable.My blood counts meet the required levels.My child is under 8 months old and has early-stage medulloblastoma.My diagnosis is a specific brain tumor called supratentorial PNET.I have anaplastic medulloblastoma, regardless of its spread or remaining tumor.My medulloblastoma is classic, not desmoplastic, and any remaining disease is smaller than 1.5 cm^2.My heart is functioning well.My medulloblastoma is considered high-risk.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (induction+consolidation chemotherapy, autologous PBSC)
- Group 2: Arm II (induction+consolidation chemotherapy, autologous PBSC)
Awards:
This trial has 2 awards, including:- 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.
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.
In how many different medical centers is this research being conducted today?
"There are 100 recruiting patients for this trial at IWK Health Centre in Halifax, Palmetto Health Richland in Columbia, McMaster Children's Hospital at Hamilton Health Sciences in Hamilton.as well as other sites 100 other locations."
Answered by AI
Are there any available positions for participants in this trial?
"The clinical trial mentioned is not currently looking for new patients, as reflected on clinicaltrials.gov. This particular study was posted on October 22nd 2007 and updated July 8th 2022. There are 2515 other trials that are open for recruitment at this time."
Answered by AI
What is methotrexate most often used to treat?
"Methotrexate is a medication that oncologists often prescribe to patients with leukemia. Additionally, it can be an effective treatment for prostate and lung cancer when used in the initial stages of care."
Answered by AI
What does the scientific community know about methotrexate from previous research?
"The first clinical trial for methotrexate was conducted in 1997 at the City of Hope Comprehensive Cancer Center. Since then, there have been a total of 4634 completed trials involving this medication. There are presently 2426 live studies underway, with a large number of these trials taking place in Halifax, Nova Scotia."
Answered by AI
What is the government's stance on methotrexate?
"Methotrexate is considered safe according to our 3-point scale, as it has progressed to Phase 3 trials and there is both supportive efficacy data and safety data available."
Answered by AI
How many people are enrolled in the trial currently?
"This study is not currently recruiting patients. It was initially posted on October 22nd, 2007 and last updated on July 8th, 2022. However, if you are searching for other studies, there are 89 clinical trials actively recruiting participants with neuroectodermal tumors and 2426 methotrexate trials admitting patients."
Answered by AI
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