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Alkylating agents
Risk-Directed Therapy for Medulloblastoma
Phase 2
Recruiting
Led By Giles W. Robinson, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months after enrollment
Awards & highlights
Study Summary
This trial is testing a new way to treat children with medulloblastoma that is based on the individual child's risk factors.
Who is the study for?
This trial is for children under 5 years with newly diagnosed medulloblastoma. They must have a certain level of organ function, no prior brain tumor treatments except surgery, and a performance score over 30. Parents can consent and participate in educational interventions.Check my eligibility
What is being tested?
The study tests molecular and clinical risk-directed therapies including chemotherapy drugs like Carboplatin, Topotecan, Etoposide; surgical procedures; Methotrexate; irradiation; and supportive care with Pegfilgrastim or Filgrastim to boost white blood cells.See study design
What are the potential side effects?
Possible side effects include lowered blood cell counts leading to infection risk, nausea, vomiting, hair loss from chemotherapy; surgical risks like bleeding or infection; irritation from radiation therapy; fatigue and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 6 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 6 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Executive function among infants and young children treated with systemic chemotherapy only compared to patients treated with systemic chemotherapy and intra-ventricular chemotherapy or delayed risk-adapted craniospinal irradiation
Pharmacotherapy
Pharmacotherapy
+3 moreSecondary outcome measures
Association of familial factors and environmental factors with cognitive late effects.
Association of familial factors and environmental factors with socioeconomic status
Medulloblastoma
+20 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Stratum S-2Experimental Treatment9 Interventions
Patients with Sonic Hedgehog subgroup 2 (SHH-2), 0-2.99 years, or M0 and 3-4.99 years, will receive systemic high-dose methotrexate (HD-MTX) and conventional chemotherapy.
Interventions: Surgery, Methotrexate, Cisplatin, Vincristine, Cyclophosphamide, Carboplatin, Topotecan, Pegfilgrastim, Filgrastim
Group II: Stratum S-1Experimental Treatment10 Interventions
Patients with SHH-1, SHH-3, SHH-4, or SHH-Not otherwise specified (NOS), 0-2.99 years, will receive intraventricular methotrexate (IVT-MTX) in parallel with systemic HD-MTX and conventional chemotherapy.
Interventions: Surgery, Methotrexate, Cisplatin, Vincristine, Cyclophosphamide, Carboplatin, Topotecan, Pegfilgrastim, Filgrastim
Group III: Stratum NExperimental Treatment11 Interventions
Patients with Medulloblastoma (MB) group 3 or group 4 (G3/G4) or MB [including Non-WNT non-SHH medulloblastoma (NWNS) NOS or otherwise indeterminate cases] (0-2.99 years) will receive systemic HD-MTX and conventional chemotherapy only for radiation delaying purposes. At 3 years of age, these patients will receive risk-stratified craniospinal irradiation (CSI).
Interventions: Surgery, Methotrexate, Cisplatin, Vincristine, Cyclophosphamide, Carboplatin, Topotecan, Etoposide, Pegfilgrastim, Filgrastim, Radiation
Group IV: Cognitive Study Group I (educational video and games)Experimental Treatment1 Intervention
Educational video and games
Group V: Cognitive Study Group II (standard-of-care control)Active Control1 Intervention
Standard-of-care (SOC) followed by educational video and games
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Topotecan
2017
Completed Phase 3
~2400
Carboplatin
2014
Completed Phase 3
~6670
Pegfilgrastim
2013
Completed Phase 3
~4410
Filgrastim
2000
Completed Phase 3
~3670
Surgical resection
2021
Completed Phase 2
~920
Methotrexate
2013
Completed Phase 4
~3800
Cisplatin
2013
Completed Phase 3
~1940
Vincristine
2003
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3770
Irradiation
2015
N/A
~490
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,493 Total Patients Enrolled
13 Trials studying Medulloblastoma
2,776 Patients Enrolled for Medulloblastoma
Giles W. Robinson, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
221 Total Patients Enrolled
2 Trials studying Medulloblastoma
89 Patients Enrolled for Medulloblastoma
Aditi Bagchi, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My disease was confirmed with brain and spine MRI and CSF test.My medulloblastoma diagnosis has been confirmed by a central review.My medulloblastoma belongs to a specific molecular subgroup.My organs are functioning well enough for me to join the study.I am under 5 years old.I am less than 3 years old.I have received treatment for medulloblastoma before.I can start treatment within 36 days after my surgery.My medulloblastoma's type has been confirmed by a central review.My parent or guardian can and is willing to sign the consent form for me.I am newly diagnosed with medulloblastoma.I have not had any treatment for my brain tumor except for steroids and surgery.I can do some activities but need help.I am under 3 years old.My cancer is a CNS embryonal tumor, not medulloblastoma.My tumor sample is available for detailed lab analysis.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum S-2
- Group 2: Stratum S-1
- Group 3: Stratum N
- Group 4: Cognitive Study Group I (educational video and games)
- Group 5: Cognitive Study Group II (standard-of-care control)
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.
Is there still room for more participants in this research project?
"Yes, this is correct. The latest information from clinicaltrials.gov shows that this study is looking for patients right now. This trial was first posted on November 1st 2022 and updated just 27 days ago on October 28th."
Answered by AI
Has the Food and Drug Administration given their seal of approval to Cisplatin?
"Cisplatin received a safety score of 2 because, while there is data supporting its safety, none of the clinical trials thus far have been able to confirm its efficacy."
Answered by AI
What are the key goals that this team of researchers is hoping to accomplish?
"The overarching objective of this study is to track the progression-free survival rate of SHH-2 infant and young child medulloblastoma patients that receive systemic HD-MTX chemotherapy over a five year period. Additionally, this research will explore secondary objectives including the correlation between cognitive late effects and familial or environmental factors, characterizing the 7OHMTX AUC0-24h in methotrexate treated infants and young children with medulloblastoma, as well as changes in executive function among infants and young children treated for medulloblastoma."
Answered by AI
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