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Alkylating agents
Multimodal Therapy for Brain Cancer
Phase 2
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 proven germinoma with Beta-HCG-positive syncytiotrophoblastic giant cell component AND/OR CSF elevation of beta-HCG to less than 50 ng/mL
Histologically proven pure germinoma with localized, nonmetastatic disease, normal CSF, and normal serum tumor markers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well giving chemotherapy, surgery, radiation therapy, and bone marrow or peripheral stem cell transplantation works in treating patients with primary CNS germ cell tumors.
Who is the study for?
This trial is for people of any age with primary CNS germ cell tumors, which are a type of brain tumor. Participants must have normal heart function and organ health, not be pregnant, use contraception if fertile, and have specific levels of certain markers in their blood or CSF. Those with prior chemotherapy or radiotherapy, living outside the US, other cancers within 5 years (except some skin cancers), or lymphoproliferative disorders can't join.Check my eligibility
What is being tested?
The study tests how well high-dose chemotherapy combined with surgery, radiation therapy, and either bone marrow or peripheral stem cell transplantation works against primary CNS germ cell tumors. The goal is to see if this approach is more effective at stopping these brain tumors from growing or spreading.See study design
What are the potential side effects?
Potential side effects include damage to healthy cells leading to fatigue, infection risk increase due to immune system suppression by chemotherapy; complications from surgery; skin irritation from radiation; and risks associated with stem cell transplantation like graft-versus-host disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of germinoma and tests show specific markers.
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My cancer is a non-spreading germinoma confirmed by tests.
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My cancer is confirmed and shows high levels of certain markers or has spread, as seen in tests.
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My heart functions normally, with no recent heart attacks, and my heart's pumping ability is good.
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I have a newly diagnosed brain tumor that originated from germ cells.
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
Find a Location
Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
230 Previous Clinical Trials
5,076,582 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,918,305 Total Patients Enrolled
Jonathan L. Finlay, MB, ChBStudy ChairChildren's Hospital Los Angeles
6 Previous Clinical Trials
180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of germinoma and tests show specific markers.I haven't had cancer in the last 5 years, except for skin cancer.My cancer is a non-spreading germinoma confirmed by tests.I have a history of cancer.My cancer is confirmed and shows high levels of certain markers or has spread, as seen in tests.My bilirubin level is below 2.0 mg/dL, but I have Gilbert's syndrome.My organs, except for my brain, are functioning well.My heart functions normally, with no recent heart attacks, and my heart's pumping ability is good.I have had a condition where my lymphocytes multiply unusually.I have a newly diagnosed brain tumor that originated from germ cells.My age does not limit my participation.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- 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.
Has this therapy been sanctioned by the Food and Drug Administration?
"Despite the absence of clinical data confirming efficacy, our team still assessed this treatment's safety to be a 2 due to its Phase 2 trial status."
Answered by AI
Is the enrollment period for this research still open?
"Confirmed. Clinicaltrials.gov data elucidates that this medical trial, initially posted on December 1st 2000 and last updated in December 2013, is not presently recruiting patients; however, 164 other studies are looking for participants currently."
Answered by AI
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