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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/NCT00392327
Registration number
NCT00392327
Ethics application status
Date submitted
25/10/2006
Date registered
26/10/2006
Date last updated
26/01/2024
Titles & IDs
Public title
Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET
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Scientific title
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
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Secondary ID [1]
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NCI-2009-00336
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Secondary ID [2]
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ACNS0332
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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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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Other interventions - Filgrastim
Treatment: Drugs - Isotretinoin
Other interventions - Laboratory Biomarker Analysis
Other interventions - Quality-of-Life Assessment
Treatment: Other - Radiation Therapy
Treatment: Drugs - Vincristine Sulfate
Active Comparator: Arm A (chemoradiotherapy) - CHEMORADIOTHERAPY: Patients undergo radiation therapy QD five days a week for 6 weeks. Patients also receive vincristine sulfate IV over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim SC or IV beginning on day 4 and continuing until blood counts recover (at least 10 days).
Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B (chemoradiotherapy) - CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm A. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm A.
Experimental: Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm A. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
MAINTENANCE THERAPY: Patients receive isotretinoin PO BID on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm A maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) - CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm B. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm C. Patients then proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive continuation therapy as in Arm C.
Treatment: Drugs: Carboplatin
Given IV
Treatment: Drugs: Cisplatin
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Other interventions: Filgrastim
Given IV or SC
Treatment: Drugs: Isotretinoin
Given PO
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Other interventions: Quality-of-Life Assessment
Ancillary studies
Treatment: Other: Radiation Therapy
Undergo radiation therapy
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Other
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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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Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma
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Assessment method [1]
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The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined.
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Timepoint [1]
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Up to 5 years
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Primary outcome [2]
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Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
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Assessment method [2]
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The Kaplan-Meier method will be used to estimate 5-year EFS, defined as the time from study enrollment to disease progression or recurrence, second malignant neoplasm, or death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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Tumor Response to Radiation Therapy for Patients With Medulloblastoma
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Assessment method [1]
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Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses.
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Timepoint [1]
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12 weeks after treatment initiation
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Secondary outcome [2]
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Tumor Response to Radiation Therapy for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
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Assessment method [2]
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Percentages of patients with responses after radiation therapy (induction therapy) are reported with 95% confidence intervals. Complete and partial responses were considered responses. SPNET is no longer recognized by WHO (World Health Organization) as a disease entity. Additional trial information can be found under PubMed® # 30332335.
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Timepoint [2]
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12 weeks after treatment initiation
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Secondary outcome [3]
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Percent Probability of Overall Survival (OS) for Patients With Medulloblastoma
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Assessment method [3]
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The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact. Estimates are reported with 95% confidence intervals. Data below represents all molecular subgroups combined.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Percent Probability of Overall Survival (OS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
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Assessment method [4]
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The Kaplan-Meier method will be used to estimate 5-year OS, defined as the time from study enrollment to death from any cause, or to date of last contact.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
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Assessment method [5]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported.
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Timepoint [5]
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6 - 12 months post diagnosis
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Secondary outcome [6]
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The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients
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Assessment method [6]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 30+/-6 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported.
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Timepoint [6]
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24 - 36 months post diagnosis
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Secondary outcome [7]
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The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients
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Assessment method [7]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 60+/-12 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported.
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Timepoint [7]
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48 - 72 months post diagnosis
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Secondary outcome [8]
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The Estimated Full-scale IQ (FSIQ) at 9+/-3 Months Post Diagnosis for SPNET Patients
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Assessment method [8]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 9+/-3 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported.
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Timepoint [8]
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6 - 12 months post diagnosis
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Secondary outcome [9]
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The Estimated Full-scale IQ (FSIQ) at 30+/-6 Months Post Diagnosis for SPNET Patients
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Assessment method [9]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 30+/-6 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported.
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Timepoint [9]
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24 - 36 months post diagnosis
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Secondary outcome [10]
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The Estimated Full-scale IQ (FSIQ) at 60+/-12 Months Post Diagnosis for SPNET Patients
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Assessment method [10]
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Post-treatment neurocognitive function was assessed. Full-scale IQ (FSIQ) is a representative measurement for neurocognitive function. FSIQ was measured by IQ tests. Assessments within the time window, from eligible and evaluable patients are reported. The time window is 60+/-12 months post diagnosis, only the assessments before progression date were reported. The Range of FSIQ is 50-150. A higher FSIQ is better. Mean and standard deviation of FSIQ were calculated and reported.
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Timepoint [10]
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48 - 72 months post diagnosis
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Secondary outcome [11]
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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for Medulloblastoma Patients
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Assessment method [11]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported.
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Timepoint [11]
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6 - 12 months post diagnosis
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Secondary outcome [12]
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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients
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Assessment method [12]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported. SPNET is no longer recognized by WHO (World Health Organization) as a disease entity. Additional trial information can be found under PubMed® # 30332335.
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Timepoint [12]
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24 - 36 months post diagnosis
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Secondary outcome [13]
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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for Medulloblastoma Patients
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Assessment method [13]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported.
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Timepoint [13]
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48 - 72 months post diagnosis
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Secondary outcome [14]
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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 9+/-3 Months Post Diagnosis for SPNET Patients
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Assessment method [14]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported.
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Timepoint [14]
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6 - 12 months post diagnosis
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Secondary outcome [15]
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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients
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Assessment method [15]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported.
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Timepoint [15]
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24 - 36 months post diagnosis
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Secondary outcome [16]
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Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients
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Assessment method [16]
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Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the patient had disease progression, only the assessments before progression date were reported. The MI is a standard T- score, and it ranges from 0 to 100. The higher score reported suggests a higher level of dysfunction. Mean and standard deviation of MI were calculated and reported.
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Timepoint [16]
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48 - 72 months post diagnosis
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Eligibility
Key inclusion criteria
- Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2
residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma
are eligible regardless of M-stage or residual tumor
- As of amendment # 2, enrollment of patients with supratentorial PNET has been
discontinued
- All patients with M4 disease are not eligible
- A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without
contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for
study eligibility
- Post-operative head MRI scan with and without contrast (preferably within 72
hours post-surgery); for patients who undergo stereotactic biopsy only, either a
pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a
post-op MRI is strongly encouraged, but not mandatory
- Spinal MRI imaging with and without gadolinium is required within 10 days of
surgery if done pre-operatively or within 28 days of surgery if done
post-operatively; for posterior fossa tumors, pre-operative MRI scans are
preferred
- Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively
or within 31 days following surgery; the optimal time for obtaining CSF is prior to
surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may
be used only if a post-operative spinal tap is contraindicated; if a spinal tap is
contraindicated and there is no ventricular CSF available, then CSF cytology can be
waived for patients with supratentorial tumors or if there is documentation of spinal
subarachnoid metastases (M3); patients who are categorized as M1 must have either an
intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a
positive lumbar CSF obtained > 7 days post-operatively
- Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of
age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life
expectancy > 8 weeks
- No previous chemotherapy or radiation therapy
- Corticosteroids should not be used during chemotherapy administration as an antiemetic
- Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4
(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 (vincristine sulfate)
- CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when
taking cyclophosphamide; aprepitant should also be used with caution with etoposide or
vincristine chemotherapy
- Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be
avoided or used with caution during or shortly after cisplatin administration and
concomitant use with amphotericin B should probably also be avoided; patients
receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or
loop diuretics concomitantly should be closely monitored for signs of ototoxicity
- Plasma levels of anticonvulsant agents should be monitored and doses adjusted
during therapy with cisplatin
- No other experimental therapy is permitted while on study
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
- Total bilirubin < 1.5 x upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT
(AST) or SGPT (ALT) must be < 5 x ULN
- Absolute neutrophil count (ANC) >= 1,000/uL
- Platelets >= 100,000/uL (untransfused)
- Hemoglobin >= 8 g/dl (may be transfused)
- Female patients who are post-menarchal must have a negative pregnancy test; lactating
female patients must agree not to breast-feed while on this trial; males or females of
reproductive potential may not participate unless they have agreed to use an effective
contraceptive method
- 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
3
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Maximum age
21
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
26/03/2007
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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
30/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
379
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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Women's and Children's Hospital-Adelaide - North Adelaide
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Recruitment hospital [2]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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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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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maryland
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Mississippi
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New Hampshire
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New Mexico
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New York
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South Dakota
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Alberta
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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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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial studies different chemotherapy and radiation therapy regimens
to compare how well they work in treating young patients with newly diagnosed, previously
untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine
sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill
more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin
may make tumor cells more sensitive to radiation therapy. It is not yet known which
chemotherapy and radiation therapy regimen is more effective in treating brain tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00392327
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Contacts
Principal investigator
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James M Olson
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00392327
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