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临床试验/NCT00602667
NCT00602667进行中（未招募）2 期

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma

St. Jude Children's Research Hospital10 个研究点 分布在 2 个国家目标入组 293 人开始时间: 2007年12月17日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中（未招募）
入组人数
293
试验地点
10
主要终点
Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important part of the two clinical trials which resulted in the best survival results for children less than 3 years of age with medulloblastoma. Most patients treated on this trial will also receive radiation which is carefully targeted to the area of the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in fewer problems with thinking and learning than radiation to the whole brain and spinal cord.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.

详细描述

All patients with medulloblastoma who were diagnosed prior to their 3rd birthday will contribute to both the biology and therapeutic primary objectives of this protocol. Furthermore patients who were ≥3 and <5 years old at the time of diagnosis will also be included in the cohort for these primary objectives as long as they meet the eligibility criteria as outlined in Amendment 8.0 of this protocol. Patients in the 3-5 year old age cohort who enrolled on previous versions of this protocol and who do not meet the criteria as outlined in Amendment 8.0 of this protocol will be excluded from the outcome analyses of the biology and therapeutic primary objectives of the protocol.

OBJECTIVES:

Primary

  • To identify patterns of methylation profiling that are associated with progression-free survival among young pediatric patients with medulloblastoma treated with risk-adapted therapy.
  • To estimate the event-free survival distribution of young medulloblastoma patients treated with risk-adapted therapy.

Secondary

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 5 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Histologically confirmed newly diagnosed CNS tumors of any of the following :
  • •Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma)
  • •Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)
  • •Pineoblastoma
  • •Atypical teratoid rhabdoid tumor (ATRT)
  • •Choroid plexus carcinoma
  • •High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma,
  • •Ependymoma (including all ependymoma histological variants)
  • •Age < 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients ≥ 3 and < 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible.
  • •Meets criteria for 1 of the following risk groups:
  • •Low-risk group:
  • •Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity
  • •Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist
  • •No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)
  • •Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated
  • •Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible
  • •Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of < 1 cm2 confirmed on postoperative CT scan or MRI
  • •Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size < 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk
  • •Desmoplastic medulloblastoma patients who are ≥3 -<5 years of age will NOT be eligible for the low risk arm of the protocol.
  • •Intermediate-risk group:
  • •Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis
  • •Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis
  • •Medulloblastoma patients who are ≥3 and < 5 yrs of age irrespective of histology and with no evidence of CNS metastasis
  • •High-risk group:
  • •Any eligible histologic diagnosis with evidence of CNS metastasis
  • •Patients with extraneural metastasis are eligible for treatment on the high-risk group
  • •PATIENT CHARACTERISTICS:
  • •Lansky performance status ≥ 30 (except for posterior fossa syndrome)
  • •WBC > 2,000/mm3
  • •Platelets > 50,000/mm3 (without support)
  • •Hemoglobin > 8 g/dL (with or without support)
  • •ANC > 500/mm3
  • •Serum creatinine < 3 times upper limit of normal (ULN)
  • •ALT < 5 times ULN
  • •Total bilirubin < 3 times ULN
  • •PRIOR CONCURRENT THERAPY:
  • •See Disease Characteristics
  • •No more than 31 days since prior definitive surgery
  • •No prior radiotherapy or chemotherapy other than corticosteroid therapy

排除标准

  • 未提供

研究组 & 干预措施

Low-Risk Patients

Experimental

Patients with GTR/M0 medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.

Note: Accrual to the low-risk medulloblastoma cohort is closed as of 12/2/2015. Accrual to the low-risk high grade glioma remains open.

干预措施: Induction Chemotherapy (Drug)

Low-Risk Patients

Experimental

Patients with GTR/M0 medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.

Note: Accrual to the low-risk medulloblastoma cohort is closed as of 12/2/2015. Accrual to the low-risk high grade glioma remains open.

干预措施: Low-Risk Therapy (Drug)

High-Risk Patients

Experimental

Patients with CNS metastatic disease will receive induction chemotherapy and high-risk therapy.

干预措施: Induction Chemotherapy (Drug)

High-Risk Patients

Experimental

Patients with CNS metastatic disease will receive induction chemotherapy and high-risk therapy.

干预措施: High-Risk Therapy (Drug)

Intermediate-Risk Therapy

Experimental

Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.

干预措施: Induction Chemotherapy (Drug)

Intermediate-Risk Therapy

Experimental

Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.

干预措施: Intermediate-Risk Therapy (Drug)

结局指标

主要结局

Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients

时间窗: From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment

Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.

Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup

时间窗: From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment

Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile.

Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients

时间窗: From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after

Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.

次要结局

  • Change in Neurostructure, Especially White Matter Volume and Integrity(From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months))
  • Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe(From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months))
  • Change in Quantitative MR Measures in the Right Frontal-parietal Regions(From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months))
  • Cyclophosphamide Clearance in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Number of Participants With Chromosomal Abnormalities(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Numbers of Patients With Gene Alterations(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Numbers of Patients With Molecular Abnormalities by Tumor Type(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Number of Successful Collections for Frozen and Fixed Tumor Samples(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Event-free Survival (EFS) Compared to Historical Controls(From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years)
  • Overall Survival (OS) Compared to Historical Controls(1 year after treatment initiation of last patient)
  • Percentage of Patients With Objective Responses Rate to Induction Chemotherapy(From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date))
  • Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity(From on-study date up to 4 months after on-study date)
  • Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity(At completion of consolidation therapy (up to 6 months after on-study date))
  • Percent of Patients With Sustained Objective Responses Rate After Consolidation(8 weeks after completion of consolidation therapy (up to 8 months after on-study date))
  • Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received(From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date))
  • Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose)
  • Percent of PET Scans With Loss of Signal Intensity(Up to 3 times during RT consolidation)
  • Concentration of Cerebrospinal Fluid Neurotransmitters(Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date)
  • Pharmacogenetic Variation on Central Nervous System Transmitters(At study enrollment (Day 0))
  • Methotrexate Clearance in Induction Cycle 1(Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX))
  • Methotrexate Clearance in Induction Cycle 2(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Clearance in Induction Cycle 3(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Clearance in Induction Cycle 4(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 1(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 2(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 3(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 1(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 2(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 4(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 3(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 4(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1(42 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2(42 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3(42 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4(42 hours from start of MTX)
  • Erlotinib Apparent Oral Clearance(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • Erlotinib Apparent Volume of Central Compartment(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • Erlotinib AUC0-24h(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose)
  • 4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • 4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • OSI-420 AUC0-24h(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • 4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose)
  • CEPM AUC0-24h in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Topotecan AUC0-24h in Consolidation Chemotherapy(Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion)
  • CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose)
  • Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan(Pre-infusion, 5 min., 1, and 3 hours from end of infusion)
  • Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan(Pre-infusion, 5 min., 1, and 3 hours from end of infusion)
  • Topotecan Clearance in Consolidation Chemotherapy(Pre-infusion, 5 min., 1, and 3 hours from end of infusion)
  • Topotecan Apparent Oral Clearance in Maintenance Chemotherapy(Pre-dose, 0.25, 1.5 and 6 hours post-dose)
  • Cyclophosphamide AUC0-24h in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • 4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Topotecan AUC0-24h in Maintenance Chemotherapy(Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose)
  • Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Verbal Fluency as Measured by Retrieval Fluency Standard Scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Rate of Local Disease Progression(1 year after completion of radiation therapy for last patient)
  • Rate of Distant Disease Progression(1 year after completion of radiation therapy for last patient)
  • Number of Participants With Chromosomal Abnormalities(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Overall Survival (OS) Compared to Historical Controls(1 year after treatment initiation of last patient)
  • Percentage of Patients With Objective Responses Rate to Induction Chemotherapy(From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date))
  • Numbers of Patients With Gene Alterations(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity(From on-study date up to 4 months after on-study date)
  • Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity(At completion of consolidation therapy (up to 6 months after on-study date))
  • Numbers of Patients With Molecular Abnormalities by Tumor Type(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Number of Successful Collections for Frozen and Fixed Tumor Samples(Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment)
  • Event-free Survival (EFS) Compared to Historical Controls(From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years)
  • Pharmacogenetic Variation on Central Nervous System Transmitters(At study enrollment (Day 0))
  • Methotrexate Volume of Central Compartment in Induction Cycle 2(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Percent of Patients With Sustained Objective Responses Rate After Consolidation(8 weeks after completion of consolidation therapy (up to 8 months after on-study date))
  • Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received(From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date))
  • Percent of PET Scans With Loss of Signal Intensity(Up to 3 times during RT consolidation)
  • Methotrexate Clearance in Induction Cycle 2(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Concentration of Cerebrospinal Fluid Neurotransmitters(Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date)
  • Number and Type of Genetic Polymorphisms(At study enrollment (Day 0))
  • Number of Participants With Endocrinopathy(End of induction therapy (approximately 16 weeks from start of treatment), end of therapy (approximately 48 weeks from start of treatment), and 6, 12, 24, 36, 48, and 60 months off therapy)
  • Growth Hormone Secretion(End of induction therapy (approximately 16 weeks from start of treatment), end of therapy (approximately 48 weeks from start of treatment), and 6, 12, 24, 36, 48, and 60 months off therapy)
  • Methotrexate Clearance in Induction Cycle 1(Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX))
  • Methotrexate Clearance in Induction Cycle 3(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Clearance in Induction Cycle 4(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 1(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 3(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 1(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Volume of Central Compartment in Induction Cycle 4(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 2(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 3(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate AUC0-66h in Induction Cycle 4(Pre-infusion and 6, 23, 42, 66 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1(42 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2(42 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4(42 hours from start of MTX)
  • Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3(42 hours from start of MTX)
  • Cyclophosphamide Clearance in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide AUC0-24h in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose)
  • Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • 4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose)
  • 4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • 4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • 4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose)
  • CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • CEPM AUC0-24h in Induction Chemotherapy(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2(Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion)
  • Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan(Pre-infusion, 5 min., 1, and 3 hours from end of infusion)
  • CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1(Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose)
  • Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan(Pre-infusion, 5 min., 1, and 3 hours from end of infusion)
  • Topotecan Clearance in Consolidation Chemotherapy(Pre-infusion, 5 min., 1, and 3 hours from end of infusion)
  • Topotecan Apparent Oral Clearance in Maintenance Chemotherapy(Pre-dose, 0.25, 1.5 and 6 hours post-dose)
  • Topotecan AUC0-24h in Consolidation Chemotherapy(Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion)
  • Topotecan AUC0-24h in Maintenance Chemotherapy(Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose)
  • Erlotinib Apparent Oral Clearance(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • Erlotinib Apparent Volume of Central Compartment(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • Erlotinib AUC0-24h(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • OSI-420 AUC0-24h(Pre-dose, 1, 2, 4, 8, and 24 hours post-dose)
  • Rate of Distant Disease Progression(1 year after completion of radiation therapy for last patient)
  • Rate of Local Disease Progression(1 year after completion of radiation therapy for last patient)
  • Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Verbal Fluency as Measured by Retrieval Fluency Standard Scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores(Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy)
  • Change in Neurostructure, Especially White Matter Volume and Integrity(From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months))
  • Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe(From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months))
  • Change in Quantitative MR Measures in the Right Frontal-parietal Regions(From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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