Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Medulloblastoma

Pinealoma

Neoplasms, Germ Cell and Embryonal

Central Nervous System Neoplasms

Nervous System Neoplasms

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Neoplasms

Brain Diseases

Central Nervous System Diseases

Supratentorial Primitive Neuroectodermal Tumor

Pineoblastoma

Pineocytoma

Neuroepithelioma

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Micronutrients

Antirheumatic Agents

Vitamins

Tretinoin

Carboplatin

Vitamin A

Retinol palmitate

Etoposide

Cyclophosphamide

Vincristine

Cisplatin

Etoposide phosphate

Thiotepa

Isotretinoin

Vorinostat

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Trace Elements

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Histone Deacetylase Inhibitors

Keratolytic Agents

Retinol

3-Dimensional Conformal Radiation Therapy

Etoposide Phosphate

Laboratory Biomarker Analysis

Peripheral Blood Stem Cell Transplantation

Vincristine Sulfate

Sarah E Leary

This pilot clinical trial studies the side effects and the best way to give vorinostat with isotretinoin and combination chemotherapy and to see how well they work in treating younger patients with embryonal tumors of the central nervous system. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as isotretinoin, vincristine sulfate, cisplatin, cyclophosphamide, and etoposide phosphate, 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 vorinostat with isotretinoin and combination chemotherapy may be an effective treatment for embryonal tumors of the central nervous system. A peripheral blood stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.

PRIMARY OBJECTIVES:

I. To investigate the feasibility of administering vorinostat (SAHA) and isotretinoin for three days prior and concomitant with cisplatin based chemotherapy over three courses of induction chemotherapy.

II. To describe the toxicity of administering vorinostat (SAHA) and isotretinoin for three days prior and concomitant with cisplatin based chemotherapy over three courses of induction chemotherapy.

III. To investigate prognostic values of histopathological classification and biological markers in the context of a feasibility study.

SECONDARY OBJECTIVES:

I. To estimate the preliminary response rate of this approach in patients with measurable residual disease (primary site and/or metastatic sites).

II. To estimate disease specific progression-free and overall survival, in the context of a feasibility study.

III. To explore the predictive values of biological markers in cerebrospinal fluid (CSF), plasma, urine tumor material in the context of a feasibility study.

OUTLINE:

INDUCTION THERAPY: Patients receive vorinostat orally (PO) once daily (QD) and isotretinoin PO twice daily (BID) on days 1-4; vincristine sulfate intravenously (IV) on days 4, 11, and 18; cisplatin IV over 6 hours on day 4; cyclophosphamide IV over 1 hour on days 5-6; and etoposide phosphate IV over 1 hour on days 4-6. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo peripheral blood stem cell (PBSC) harvesting after each course.

CONSOLIDATION THERAPY: Within 6 weeks (10 weeks if patient is re-staged) after completion of induction therapy, patients receive carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1-2. Patients also receive autologous PBSC rescue infusion over 6 hours on day 4. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks later, patients with M0 non-desmoplastic medulloblastoma also undergo conformal radiotherapy\* to the tumor bed.

NOTE: \*Patients with supratentorial primary tumors or metastatic disease undergo radiotherapy at the discretion of treating physician.

MAINTENANCE THERAPY: Beginning 4 weeks after completion of radiotherapy or immediately after completion of consolidation therapy, patients receive vorinostat PO QD on days 1, 3, 5, 6, 8, 10, 12, and 13 and isotretinoin PO BID on days 1-14. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System

A Feasibility Study of Vorinostat (SAHA) Combined With Isotretinoin and Chemotherapy in Infants With Embryonal Tumors of the Central Nervous System

Will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Simon's two-stage optimal design will be used to assess feasibility.

Will be assessed by single-nucleotide polymorphism (SNP) analysis and gene expression analysis. Loss of heterozygosity (LOH) analysis and copy number analysis (CNA) will be performed using dChip SNP software (or R bioconductor package) for the paired samples. Association of copy number (and LOH) with gene expression data will be explored. Correlation analysis (Pearson or Spearman Correlation, as appropriate) will be used to estimate the strength of association between each SNP and expression signal. The multiplicity issue will be addressed through estimating the False Discovery Rate.

Separate exact confidence interval estimates of objective responses following induction therapy will be constructed for patients with medulloblastomas (MBs) and PNETs. Cumulative incidence of objective responses as a function of course of therapy will also be provided.

Kaplan-Meier estimates of distributions of PFS will be provided. If sample sizes allow, these Kaplan-Meier estimates will be produced separately for patients with MBs and PNETs.

Kaplan-Meier estimates of distributions of OS will be provided. If sample sizes allow, these Kaplan-Meier estimates will be produced separately for patients with MBs and PNETs.

Frequency of the markers of interest present in this cohort will be provided and their associations with disease outcome will be explored. Similarly if sample size constraints make such analyses feasible, the associations between the markers of interest and clinical and demographic variables will be explored in a descriptive fashion.

National Cancer Institute (NCI)

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified

Reproductive Control Agents

Hematinics

Bone Density Conservation Agents

Leucovorin

Levoleucovorin

Methotrexate

Calcium

Lenograstim

Folic Acid

Podophyllotoxin

Calcium, Dietary

Vitamin B Complex

Hormones

Antimetabolites

Folic Acid Antagonists

Adjuvants, Immunologic

Antidotes

Protective Agents

Folinic Acid

Folate

Vitamin B9

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.

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.

Autologous Hematopoietic Stem Cell Transplantation

Filgrastim

Leucovorin Calcium

Quality-of-Life Assessment

Claire M Mazewski

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.

PRIMARY OBJECTIVES:

I. To determine if treatment of infants with high risk primitive neuroectodermal tumors (PNET) central nervous system (CNS) tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell rescue results in a higher complete response rate then the same regimen without methotrexate.

SECONDARY OBJECTIVES:

I. To determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors (AT/RT) from primitive neuroectodermal tumors (PNETs) and possibly identifying other markers of value for stratification within the group of PNETs.

II. To determine if event free survival (EFS) and patterns of failure differ between the methotrexate arm versus the arm without methotrexate.

III. To compare the acute, chronic and late effects of these two very intensive regimens, especially as to the tolerance of the same consolidation regimen following the differing induction regimens.

IV. To compare the gastrointestinal and nutritional toxicities of these intense regimens.

V. To describe and compare the quality of life outcomes and neuropsychological effects of these intense systemic therapies.

OUTLINE: Patients are randomized to 1 of 2 treatment arms

INDUCTION THERAPY:

ARM I: 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; and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

ARM II: 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 orally (PO) every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Once 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. Patients also receive G-CSF IV or SC beginning 24 hours after the completion of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

In both arms, patients with stable disease or partial response after induction therapy proceed to second-look surgery followed by consolidation therapy. Patients with a complete response after induction therapy proceed directly to consolidation therapy.

CONSOLIDATION THERAPY: Beginning no more than 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 peripheral blood stem cells (PBSC) IV on day 4. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for 4 years and then annually thereafter.

Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children &lt; 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. the Same Therapy Without Methotrexate

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.

The number of patients will be reported for this analysis by Molecular Sub-types of MB, CNS-PNETs/EBTs

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.

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.

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.

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.

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.

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.

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.

The number of patients who had "Diabetes Insipidus" and on DDAVP will be reported for this analysis due to small numbers..

The number of patients who had secondary malignancy will be reported for this analysis due to small numbers.

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.

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.

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.

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.

Children's Oncology Group

Adverse Events/Serious Adverse Events were reported for all eligible patients (n=77) by treatment arm in the study. The total number of participants at risk represents total number of eligible patients in the study by treatment arm.

Patients receive vincristine sulfate IV 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 filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Arm I (Patients Treated Without Methotrexate (MTX))

Patients receive vincristine sulfate IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally 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 filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Patients Treated With MTX)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Only eligible patients are included in the baseline characteristics. Seven patients were excluded in each treatment arm.

Data will not be available for reporting Secondary Outcome Measure #15 until December 2018 due to the limiting factor, being that the tissue has not yet been shipped from the Biopath Center to the designated laboratory for analysis.

Results Reporting Coordinator

The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.

Per protocol, only evaluable patients are included.

Number of Patients Who Have Either a Complete Response (CR) Rate or No Complete Response Rate

12 patients without molecular data, because of lack of sufficient materials or poor quality of the data, were not included in this analysis.

Number of Participants With Molecular Sub-types of MB, CNS-PNETs/EBTs Represented in the ACNS0334 Cohort

The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.

Per protocol all eligible patients randomized to treatment should be included in the analysis.

Percentage of Participants With Event Free Survival (EFS)

The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.

All Eligible Participants who relapsed/disease progressed in the study.

Patterns of Failure

Difference in incidence for the two treatment regimens will be compared using log-rank test.

Percentage of Participants With Any Acute Adverse Events

The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.

Number of Participants With Acute Hearing Loss and No Acute Hearing Loss

Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism

Number of Participants With Chronic Central Hypothyroidism

Number of Participants With Chronic Low Somatomedin C

Number of Participants With Chronic Diabetes Insipidus

Number of Participants With Secondary Malignancies

The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.

Number of Participants With Chronic/Late Hearing Loss and No Chronic/Late Hearing Loss

Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.

GI Tox Induction Cycle I

No GI Tox Induction Cycle I

GI Tox Induction Cycle II

No GI Tox Induction Cycle II

GI Tox Induction Cycle III

No GI Tox Induction Cycle III

GI Tox Consolidation Cycle I

No GI Tox Consolidation Cycle I

GI Tox Consolidation Cycle II

No GI Tox Consolidation Phase II

GI Tox Consolidation Cycle III

No GI Tox Consolidation Cycle III

Rates of Gastrointestinal Toxicities

Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.

Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.

Nutritional Disorders Induction Cycle I

No Nutritional Disorders Induction Cycle I

Nutritional Disorders Induction Cycle II

No Nutritional Disorders Induction Cycle II

Nutritional Disorders Induction Cycle III

No Nutritional Disorders Induction Cycle III

Nutritional Disorders Consolidation Cycle I

No Nutritional Disorders Consolidation Cycle I

Nutritional Disorders Consolidation Cycle II

No Nutritional Disorders Consolidation Cycle II

Nutritional Disorders Consolidation Cycle III

No Nutritional Disorders Consolidation Cycle III

Rates of Nutritional Toxicities

Total Quality of Life Score

Intelligence Quotient

Processing Speed Index

Of the 77 eligible participants in ACNS0334, only 4 patients completed assessments in ALTE07C1 study. The targeted number of participants to achieve target power and statistically reliable results was not achieved and therefore the data is statistically uninterpretable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System	NCT00867178	Medulloblastoma Pineoblastoma Supratentorial ...	3-Dimensional C... Carboplatin Cisplatin Cyclophosphamid... Etoposide Phosp... Isotretinoin Laboratory Biom... Peripheral Bloo... Thiotepa Vincristine Sul... Vorinostat	2 Months - 47 Months	National Cancer Institute (NCI)
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma	NCT00336024	Anaplastic Medu... Medulloblastoma Supratentorial ... Untreated Child...	Autologous Hema... Carboplatin Cisplatin Cyclophosphamid... Etoposide Filgrastim Laboratory Biom... Leucovorin Calc... Methotrexate Quality-of-Life... Thiotepa Vincristine Sul...	- 2 Years	Children's Oncology Group

Spots Global Cancer Trial Database for supratentorial embryonal tumor, not otherwise specified