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Alkylating agents

Chemotherapy + Radiation Therapy for Brain Cancer

Phase 2
Recruiting
Led By Shannon M MacDonald
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
Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 21 days prior to enrollment and within 35 days prior to start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded
Patients must be >= 3 years and < 30 years at the time of study enrollment
Must not have
Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well different combinations of chemotherapy and radiation therapy work in treating patients with non-germinomatous germ cell tumors that have not spread to other parts of the brain or body.

Who is the study for?
This trial is for children and young adults aged 3 to less than 30 with a localized brain tumor called NGGCT, without prior tumor-directed therapy other than surgery or steroids. Participants must have specific blood counts, organ function, no metastatic disease, not be pregnant or breastfeeding, and agree to use contraception if sexually active.
What is being tested?
The study tests how well chemotherapy combined with radiation therapy works based on the patient's response to initial chemotherapy. It aims to optimize treatment by either adjusting radiation levels or using higher dose chemo followed by stem cell transplant before conventional radiation.
What are the potential side effects?
Possible side effects include those typical of chemotherapy such as nausea, hair loss, fatigue, risk of infection due to low blood counts; and from radiation like skin irritation and fatigue. High-dose chemo may also cause mouth sores and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific brain tumor with certain marker levels.
Select...
I am between 3 and 29 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My tumor is a mature teratoma with normal marker levels.
Select...
My tumor is not in the brain's ventricles but in areas like the basal ganglia or thalamus.
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My cancer has spread, as confirmed by tests.
Select...
I have only had surgery or corticosteroids for my NGGCT diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Failure rate
Spinal failure rate
Secondary study objectives
Overall survival (OS)
Patterns of disease recurrence/failure
Progression-free survival (PFS)
+2 more
Other study objectives
Change in adaptive functioning within each arm
Change in health-related quality of life between the two treatment arms
Change in health-related quality of life within each arm
+10 more

Awards & Highlights

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: Plan B (chemotherapy, HDCSCR, second-look surgery if needed)Experimental Treatment13 Interventions
See Outline in Detailed Description.
Group II: Plan A (chemotherapy, WVSCI, second-look surgery if needed)Experimental Treatment11 Interventions
See Outline in Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ifosfamide
2010
Completed Phase 4
~3350
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Carboplatin
2014
Completed Phase 3
~6120
Etoposide
2010
Completed Phase 3
~2960
Filgrastim
2000
Completed Phase 3
~3690
Mesna
2003
Completed Phase 2
~1380
Pegfilgrastim
2013
Completed Phase 3
~4440
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Radiation Therapy
2017
Completed Phase 3
~7250
Thiotepa
2008
Completed Phase 3
~2120

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,838 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,878 Total Patients Enrolled
Shannon M MacDonaldPrincipal InvestigatorChildren's Oncology Group

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04684368 — Phase 2
Central Nervous System Choriocarcinoma Research Study Groups: Plan A (chemotherapy, WVSCI, second-look surgery if needed), Plan B (chemotherapy, HDCSCR, second-look surgery if needed)
Central Nervous System Choriocarcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04684368 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684368 — Phase 2
~95 spots leftby Dec 2029
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