A Phase 3 interventional study of filgrastim and cisplatin in Brain and Central Nervous System Tumors, sponsored by St. Jude Children's Research Hospital. Completed at 9 sites in 3 countries. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by St. Jude Children's Research Hospital · Phase 3, Interventional, and Treatment
Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
EXPLORATORY OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease risk (high-risk disease vs average-risk disease).
Patients in both strata undergo peripheral blood stem cell or bone marrow harvest.
Stratum 1 (high-risk group):
Stratum 2 (average-risk group):
Some patients undergo a neuropsychology assessment at baseline, before chemotherapy, and then annually for 5 years.
After completion of study therapy, patients are followed every 3 months until month 30 (2.5 years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis.
699 studies on the registry are indexed under Central Nervous System Neoplasms; 66 are open to participants now.
This study's enrollment of 416 is above the median of 35 across 487 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
confirmed diagnosis of 1 of the following:
Meets one of the following risk criteria:
Average-risk disease
T4 disease eligible if all of the following are true:
High-risk disease meeting one of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy
Biological: filgrastim · Drug: cisplatin · Drug: cyclophosphamide · Drug: vincristine · Procedure: autologous hematopoietic stem cell transplantation · Radiation: radiation therapy
Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy
Biological: filgrastim · Drug: cisplatin · Drug: cyclophosphamide · Drug: vincristine · Procedure: autologous hematopoietic stem cell transplantation · Radiation: radiation therapy
Given subcutaneously
Also known as: Neupogen(R), G-CSF
Given IV
Also known as: Platinol-AQ(R)
Given IV
Also known as: Cytoxan(R)
Given IV
Also known as: Oncovin(R)
Patients undergo autologous stem cell transplantation
Also known as: autologous HSCT
Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.
Also known as: RT, Craniospinal radiotherapy
Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Time frame: 2 years after tumor cell analysis in 122 participants
Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
Time frame: 2 years after tumor cell analysis in 122 participants
Frequency of Mutations Associated With SHH and WNT Tumors
The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.
Time frame: within 3.5 years following completion of accrual
Reading Decoding Composite Scores in the Intervention and Standard of Care Groups
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).
Time frame: 5 years postdiagnosis
Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa
To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.
Time frame: Annually for 6 years post irradiation
Associative Memory for Two Risk Group at Enrollment
Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
Time frame: At enrollment
Associative Memory for Two Risk Group at 5 Years After Enrollment
Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
Time frame: At 5 years after enrollment
Processing Speed for Two Risk Group at Enrollment
Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time frame: At enrollment
Processing Speed for Two Risk Group at 5 Years After Enrollment
Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time frame: At 5 years after enrollment
Perceptual Speed for Two Risk Group at Enrollment
Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time frame: At enrollment
Perceptual Speed for Two Risk Group at 5 Years After Enrollment
Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
Time frame: At 5 years after enrollment
416 participants were enrolled between 9/9/2003 and 3/7/2013.
| Milestone | Average-Risk Group | High-Risk Group |
|---|---|---|
| Started | 269 | 144 |
| Completed | 251 | 120 |
| Not completed | 18 | 24 |
| Withdrew: Still on therapy | 2 | 0 |
| Withdrew: Bone involvement confirmed by bone scan | 0 | 1 |
| Withdrew: Excessive toxicity | 6 | 5 |
| Withdrew: Non-specified | 3 | 5 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Physician decision | 4 | 1 |
| Withdrew: Progressive disease | 1 | 11 |
The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
| probability of PFS at 2 years | Overall Study | Average-Risk Group | High-Risk Group |
|---|---|---|---|
| Positive ERBB2 | 79.2 (70.4 to 88.0) | 83.3 (73.5 to 93.1) | 69.6 (50.8 to 88.4) |
| Negative ERBB2 | 86.7 (76.9 to 96.5) | 93.5 (85.1 to 100) | 71.4 (48.9 to 93.9) |
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
| probability of PFS at 2 years | ERBB2 Positive & Average Risk | ERBB2 Positive & High Risk | ERBB2 Negative & Average Risk | ERBB2 Negative & High Risk |
|---|---|---|---|---|
| Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group. | 83.3 (73.5 to 93.1) | 69.6 (50.8 to 88.4) | 93.5 (85.1 to 100) | 71.4 (48.9 to 93.9) |
The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.
| Participants | SHH Pathway - In/Del Somatic | WNT Pathway - In/Del Somatic | SHH Pathway - In/Del Germline | WNT Pathway - In/Del Germline | SHH Pathway - SNV Somatic | WNT Pathway - SNV Somatic | SHH Pathway - SNV Germline | WNT Pathway - SNV Germline |
|---|---|---|---|---|---|---|---|---|
| PTCH1 | 7 | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| DDX3X | 0 | 0 | 0 | 0 | 3 | 7 | 0 | 0 |
| TP53 | 0 | 0 | 0 | 0 | 5 | 3 | 0 | 0 |
| KMT2D | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| SUFU | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| CREBBP | 1 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| GLI2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| TCF4 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| PTEN | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| KMT2C | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 |
| FBXW7 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
| GSE1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| CTNNB1 | 0 | 0 | 0 | 0 | 1 | 18 | 0 | 0 |
| SMARCA4 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 |
| PIK3CA | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 |
| APC | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| EPHA7 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| ARID1A | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| ARID2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| ATM | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| BRCA2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).
| score on a scale | Intervention | Standard of Care |
|---|---|---|
| Baseline | 104.1 ± 1.902 | 102.4 ± 2.604 |
| Change over time | -1.51 ± 0.4849 | -1.17 ± 0.4883 |
To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.
| Participants | Average-Risk Group |
|---|---|
| Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa | 6 |
Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
| score on a scale | Average Risk Group | High Risk Group |
|---|---|---|
| Associative Memory for Two Risk Group at Enrollment | 93.61 ± 22.25 | 98.04 ± 18.56 |
Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.
| score on a scale | Average Risk Group | High Risk Group |
|---|---|---|
| Associative Memory for Two Risk Group at 5 Years After Enrollment | 98.73 ± 16.94 | 93.58 ± 13.7 |
Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
| score on a scale | Average Risk Group | High Risk Group |
|---|---|---|
| Processing Speed for Two Risk Group at Enrollment | 83.98 ± 18.53 | 87.29 ± 19.73 |
Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.
| score on a scale | Average Risk Group | High Risk Group |
|---|---|---|
| Processing Speed for Two Risk Group at 5 Years After Enrollment | 84.21 ± 24.36 | 75.71 ± 25.71 |
Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
| score on a scale | Average Risk Group | High Risk Group |
|---|---|---|
| Perceptual Speed for Two Risk Group at Enrollment | 82.06 ± 19.99 | 90.04 ± 18.23 |
Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.
| score on a scale | Average Risk Group | High Risk Group |
|---|---|---|
| Perceptual Speed for Two Risk Group at 5 Years After Enrollment | 78.68 ± 21.58 | 72.29 ± 27.32 |
Collected over Adverse events (AEs) are reported through 9/17/2013 and include all grade 3, 4 and 5 events occurring during treatment to 30 days after treatment end, and events occurring >30 days after treatment end and felt to be possibly related to protocol treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Average-Risk Group | — | 17/269 (6.3%) | 236/269 (87.7%) |
| High-Risk Group | — | 17/144 (11.8%) | 118/144 (81.9%) |
| Event | Average-Risk Group | High-Risk Group |
|---|---|---|
| CNS necrosis/cystic progressionNervous system disorders | 1/269 | 3/144 |
| SeizureNervous system disorders | 3/269 | 3/144 |
| Infection with normal ANC or Grade 1 or 2 neutrophils, bloodInfections and infestations | 0/269 | 2/144 |
| Leak, cerebrospinal fluid (CSF)Nervous system disorders | 0/269 | 2/144 |
| Febrile neutropeniaInfections and infestations | 2/269 | 0/144 |
| Infection with unknown ANC, meninges (meningitis)Infections and infestations | 2/269 | 0/144 |
| Pleural effusion (non-malignant)Respiratory, thoracic and mediastinal disorders | 2/269 | 0/144 |
| Supraventricular and nodal arrhythmia - sinus bradycardiaCardiac disorders | 0/269 | 1/144 |
| Cardiac general - otherCardiac disorders | 0/269 | 1/144 |
| Thrombotic microangiopathyVascular disorders | 0/269 | 1/144 |
| Event | Average-Risk Group | High-Risk Group |
|---|---|---|
| Febrile neutropeniaInfections and infestations | 172/269 | 77/144 |
| Infection, bloodInfections and infestations | 55/269 | 24/144 |
| VomitingGastrointestinal disorders | 53/269 | 21/144 |
| Allergic reaction/hypersensitivity (including drug fever)Immune system disorders | 39/269 | 23/144 |
| NauseaGastrointestinal disorders | 27/269 | 20/144 |
| Pain, abdomen NOSGeneral disorders | 33/269 | 17/144 |
| Infection - otherInfections and infestations | 25/269 | 16/144 |
| DiarrheaGastrointestinal disorders | 23/269 | 14/144 |
| HypotensionCardiac disorders | 16/269 | 14/144 |
| Infection with unknown ANC, bloodInfections and infestations | 17/269 | 13/144 |
Participants had a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).
| Age, Continuous(Years) | Average-Risk Group | High-Risk Group | Total |
|---|---|---|---|
| Mean | 9.15 ± 4.08 | 8.66 ± 3.93 | 8.98 ± 4.03 |
| Age, Continuous(years) | Average-Risk Group | High-Risk Group | Total |
|---|---|---|---|
| Median | 8.42 (3.06 to 21.56) | 7.87 (3.13 to 20.43) | 8.33 (3.06 to 21.56) |
| Sex: Female, Male(Participants) | Average-Risk Group | High-Risk Group | Total |
|---|---|---|---|
| Female | 105 | 56 | 161 |
| Male | 164 | 88 | 252 |
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Filgrastim · Cisplatin · Cyclophosphamide · Vincristine
Central Nervous System Neoplasms →
St. Jude Children's Research Hospital →