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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00336024
Registration number
NCT00336024
Ethics application status
Date submitted
8/06/2006
Date registered
12/06/2006
Date last updated
25/09/2023
Titles & IDs
Public title
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
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Scientific title
A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. the Same Therapy Without Methotrexate
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Secondary ID [1]
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NCI-2009-00338
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Secondary ID [2]
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ACNS0334
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaplastic Medulloblastoma
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Medulloblastoma
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Supratentorial Embryonal Tumor, Not Otherwise Specified
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Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
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Condition category
Condition code
Cancer
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Children's - Brain
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Cancer
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Brain
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Cancer
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Children's - Other
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Autologous Hematopoietic Stem Cell Transplantation
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Etoposide
Other interventions - Filgrastim
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Methotrexate
Other interventions - Quality-of-Life Assessment
Treatment: Drugs - Thiotepa
Treatment: Drugs - Vincristine Sulfate
Active Comparator: Arm I (induction+consolidation chemotherapy, autologous PBSC) - 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.
Experimental: Arm II (induction+consolidation chemotherapy, autologous PBSC) - 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.
Treatment: Surgery: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC resuce
Treatment: Drugs: Carboplatin
Given IV
Treatment: Drugs: Cisplatin
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Etoposide
Given IV
Other interventions: Filgrastim
Given IV or SC
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin Calcium
Given IV or orally
Treatment: Drugs: Methotrexate
Given IV
Other interventions: Quality-of-Life Assessment
Ancillary studies
Treatment: Drugs: Thiotepa
Given IV
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate
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Assessment method [1]
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At the end of consolidation, the number of evaluable patients treated with intensive chemotherapy with methotrexate who achieved CR or not will be compared to those who achieved CR or not after treated with the same intensive chemotherapy without methotrexate. The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test. Complete Response (CR) requires: CR for target lesions: disappearance of all target lesions, CR for non-target lesions: disappearance of all non-target lesions and no new lesions. No CR is any response not fitting the definition of CR.
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Timepoint [1]
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At the end of consolidation treatment
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Secondary outcome [1]
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Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort
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Assessment method [1]
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The number of patients will be reported for this analysis by Molecular Sub-types of MB, CNS-PNETs/EBTs
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Timepoint [1]
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At baseline
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Secondary outcome [2]
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Percentage of Participants With Event Free Survival (EFS)
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Assessment method [2]
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EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1.
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Timepoint [2]
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Baseline to up to 5 years
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Secondary outcome [3]
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Patterns of Failure
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Assessment method [3]
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The patterns of failure for relapse/disease progression will be provided for patients treated with/without methotrexate drug in three categories, namely local, distant, and both local and distant. The number of patients with each type of failure will be listed per arm. The two groups will be compared to determine if the pattern of failure distribution is different between the two arms using Fisher exact test.
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Timepoint [3]
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Baseline to up to 5 years
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Secondary outcome [4]
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Percentage of Participants With Any Acute Adverse Events
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Assessment method [4]
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Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test.
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Timepoint [4]
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Beginning of treatment to the end of consolidation
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Secondary outcome [5]
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Number of Participants With Acute Hearing Loss and No Acute Hearing Loss
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Assessment method [5]
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Per protocol, hearing was assessed pretreatment and at regular specified intervals during treatment and off therapy, using DPOAE, audiogram or Brainstem Evoked Auditory. Per CTCAE V4.0 grade 3 Hearing impaired is defined as follows; Pediatric (on a 1,2,3,4, 6 and 8 kHz audiogram): hearing loss sufficient to indicate therapeutic intervention, including hearing aids, threshold shift >20 dB at 3 kHz and above in at least one ear, additional speech-language related services as indicated. Per CTCAE V4.0 grade 4 Hearing impaired is defined as follows; Pediatric Audiologic indication for cochlear implant and additional speech-language related services as indicated.
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Timepoint [5]
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Beginning of treatment to the end of consolidation
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Secondary outcome [6]
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Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism
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Assessment method [6]
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Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. "Normal" and "Abnormal" are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than "Institutional" Normal or equal to "Institutional" Normal with TSH level greater than "Institutional" Normal.
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Timepoint [6]
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Off-treatment up to 9 years
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Secondary outcome [7]
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Number of Participants With Chronic Central Hypothyroidism
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Assessment method [7]
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Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. "Normal" and "Abnormal" are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than "Institutional" Normal with TSH less than or equal to "Institutional" Normal.
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Timepoint [7]
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Off-treatment up to 9 years
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Secondary outcome [8]
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Number of Participants With Chronic Low Somatomedin C
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Assessment method [8]
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Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run.
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Timepoint [8]
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Off-treatment up to 9 years
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Secondary outcome [9]
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Number of Participants With Chronic Diabetes Insipidus
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Assessment method [9]
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The number of patients who had "Diabetes Insipidus" and on DDAVP will be reported for this analysis due to small numbers..
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Timepoint [9]
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Beginning of off-treatment to up to 9 years
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Secondary outcome [10]
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Number of Participants With Secondary Malignancies
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Assessment method [10]
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The number of patients who had secondary malignancy will be reported for this analysis due to small numbers.
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Timepoint [10]
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Off-treatment up to 9 years
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Secondary outcome [11]
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Number of Participants With Chronic/Late Hearing Loss and No Chronic/Late Hearing Loss
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Assessment method [11]
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The number of patients who are reported to have abnormal hearing, graded according to CTCAE 4.0 or not, with onset while on therapy or when off therapy which persisted after off therapy will be reported and will be compared using Fisher exact test.
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Timepoint [11]
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Off-treatment up to 9 years
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Secondary outcome [12]
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Rates of Gastrointestinal Toxicities
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Assessment method [12]
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Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.
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Timepoint [12]
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Beginning of treatment to the end of consolidation
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Secondary outcome [13]
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Rates of Nutritional Toxicities
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Assessment method [13]
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Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.
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Timepoint [13]
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Beginning of treatment to the end of consolidation
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Secondary outcome [14]
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Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).
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Assessment method [14]
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Three tools are used to assess intelligence (IQ) depending on age. The range of IQ scores is 40-160 (mean=100, SD=15); range for the Processing Speed Index (PSI)=45-155. Higher scores represent better functioning. (1) Wechsler Preschool and Primary Scale of Intelligence-4th Edition (WPPSI-IV) is used for ages 2.5 to 6 years. Bug Search and Cancellation subtests are summed to calculate PSI. (2) Wechsler Intelligence Scales for Children-5th Edition (WISC-V) is used for ages 6 - 16 years. Symbol Search and Coding subtests are summed to calculate PSI. (3) Wechsler Adult Intelligence Scales-4th Edition (WAIS-IV) is used for ages 16 and older. Symbol Search and Coding subtests are summed to calculate PSI.
The Pediatric Quality of Life Inventory Version 4 (PedsQL) measures health-related quality of life (QOL). Parents complete the measure for children ages 2-17, and patients > 18 complete a self-report version. Total scores range from 0-100, with higher scores representing better QOL.
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Timepoint [14]
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60 months (+/- 3 months)
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Eligibility
Key inclusion criteria
- High-risk medulloblastoma defined by any of the following:
- > 1.5 cm^2 residual disease for any medulloblastoma histology, or
- Lumbar cerebral spinal fluid (CSF) cytology positive for tumor cells by analysis
of fluid collected either before definitive surgery or at least 10 days after
definitive surgery unless contraindicated, or
- Magnetic resonance imaging (MRI) evidence of M2 or M3 metastatic disease, or
- M4 disease
- Supratentorial primitive neuroectodermal tumor (PNET) (any M-stage) will be eligible
for study entry
- Children less than 8 months of age at the time of definitive surgery with or without
measurable radiographic residual tumor with M0 stage medulloblastoma will be eligible
for study entry
- Patients with anaplastic medulloblastoma are eligible regardless of M-stage or
residual tumor
- Patients with M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically
measurable residual disease < 1.5 cm^2 are eligible
- Cranial MRI (with and without gadolinium) must be done pre-operatively;
post-operatively, cranial MRI (with and without gadolinium) must be done, preferably
within 48 hours of surgery; entire spinal MRI must be obtained either pre-operatively
(with gadolinium) or post-operatively (at least 10 days following surgery) prior to
study enrollment (with and without gadolinium); patients with MRI evidence of spinal
disease are eligible for this study
- Evaluation of lumbar CSF cytology (cytospin preparation for microscopic evaluation)
must be performed either pre-operatively or at least 10 days after definitive surgery
unless contraindicated
- Patient must have a life expectancy > 8 weeks
- Patient must have received no prior radiation therapy or chemotherapy other than
corticosteroids; corticosteroids are allowable for all patients
- Creatinine clearance or radioisotope glomerular filtration rate >= 60 mL/min
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamic pyruvic transaminase (SGPT) (alanine transaminase [ALT]) < 2 x ULN for
age
- Shortening fraction >= 27% by echocardiogram, or
- Ejection fraction >= 47% by radionuclide angiogram
- No evidence of dyspnea at rest
- Pulse oximetry > 94% on room air
- Peripheral absolute neutrophil count (ANC) > 1,000/uL
- Platelet count > 100,000/uL (transfusion independent)
- Hemoglobin greater than 8 g/dL (may have received red blood cell [RBC] transfusions
allowed)
- Hold trimethoprim/sulfamethoxazole (Bactrim) on the day of high-dose methotrexate
(HDMTX) infusion and continue to hold until the methotrexate level is less than 0.1
micromolar (1 x 10-7 M)
- Avoid probenecid, penicillins, cephalosporins, aspirin, proton pump inhibitors and
nonsteroidal anti-inflammatory drug (NSAIDS) on the day of methotrexate and continue
until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M) as renal
excretion of methotrexate is inhibited by these agents
- Avoid IV contrast media, urinary acidifiers, phenytoin, and fosphenytoin on the day of
methotrexate and until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M)
- Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and
carbamazepine) should be avoided
- Clinically significant drug interactions have been reported when using vincristine
with strong cytochrome P450 (CYP450) family 3 subfamily A member 4 (3A4) inhibitors
and inducers; selected strong inhibitors of cytochrome P450 3A4 include azole
antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong
inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and
St. John's wort; the use of these drugs should be avoided with vincristine
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
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Minimum age
No limit
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Maximum age
2
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
91
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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The Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment postcode(s) [4]
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6008 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Alberta
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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Puerto Rico
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San Juan
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial is studying two different combination chemotherapy regimens
to compare how well they work in treating young patients with newly diagnosed supratentorial
primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional
intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which
combination chemotherapy regimen is more effective when given before a peripheral stem cell
transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00336024
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Claire M Mazewski
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Children's Oncology Group
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00336024
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