New Diagnosis

CNS germ-cell tumors

• ACNS1123
  Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
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  Title Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors Tumor Type Newly diagnosed localized NGGCT or localized germinoma Description This protocol aims to reduce the burden of treatment on children with central nervous system (CNS) germ-cell tumors, including both germinoma and localized non-germinomatous germ-cell tumors (NGGCT). Thus, this study is a follow-up to two previous COG studies, and utilizes Major Eligbility Age: 3-21 years Tumor: Newly diagnosed localized NGGCT or localized germinoma Exclusion: metastatic disease, mature teratoma + normal tumor markers, tumors outside of the ventricles (i.e., basal ganglia, thalamus) Clinicaltrials.gov ID NCT01602666

Diffuse Intrinsic Pontine Glioma (DIPG)

• ACNS0927
  A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)
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  Title A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG) Tumor Type Newly diagnosed DIPG Description This is a Phase 1/2 study that is seeking to identify the maximum tolerated dose of suberoylanilide hydroxamic Major Eligbility Age: >36m to <21 years Tumor: newly diagnosed DIPG Performance status: >50% Exclusion: Must have had no prior therapy other than steroids, must not have enzyme-inducing anti-seizure medication Clinicaltrials.gov ID NCT01189266

• PBTC033 – Diffuse Intrinsic Pontine Glioma (DIPG)
  A Phase I/ II Study of ABT-888, an Oral Poly( ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children With Newly Diagnosed Diffuse Pontine Gliomas (DIPG)
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  Title A Phase I/ II Study of ABT-888, an Oral Poly( ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children With Newly Diagnosed Diffuse Pontine Gliomas (DIPG) Tumor Type diffuse intrinsic pontine glioma (DIPG) Description This study is testing the toxicity and efficacy of this combination in the treatment of children with newly diagnosed diffuse intrinsic pontine glioma (DIPG). It is a phase I/II study of a combination of ABT-888, a PARP inhibitor during radiation for the treatment of children with newly diagnosed diffuse intrinsic pontine glioma (DIPG). This will be followed by maintenance therapy of ABT-888 in combination with temozlomide after radiation has been completed. The PARP enzyme works by repairing DNA breaks. Inhibiting this enzyme may act to prevent tumor cell resistance/recovery from the DNA breaks instituted by either radiation therapy or chemotherapy such as temozolomide. Major Eligbility Age: < 21 years Tumor: DIPG (may be radiographic diagnosis) Performance status: ≥50 Exclusion: may not have received any prior therapy other than surgery and steroids, uncontrolled seizures Timing: Protocol therapy must start within 30 days of surgery or radiographic diagnosis, whichever is later  Clinicaltrials.gov ID NCT01507324

Embryonal tumors: medulloblastoma, PNET, ATRT

• PBTC026 – Embryonal tumors
  A Feasibility Study of SAHA combined with Isotretinoin and Chemotherapy in Infants with Embryonal Tumors of the Central Nervous System
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  Title A Feasibility Study of SAHA combined with Isotretinoin and Chemotherapy in Infants with Embryonal Tumors of the Central Nervous System Tumor Type medulloblastoma or sPNET Description This study seeks to improve the outcomes of very young children with medulloblastoma or primitive neuroectodermal tumor (PNET). The treatment will involve high-dose chemotherapy, stem-cell rescue, and radiotherapy as well the addition of two new agents: SAHA and Isoretinoin. These agents have preclinical and early clinical evidence of efficacy against these tumors. Major Eligbility Age: 2-48 months Must have pre-treatment tumor tissue available Exclusion: any previous valproic acid, previous chemotherapy, ATRT, or Desmoplastic M0 Medulloblastoma Clinicaltrials.gov ID NCT00867178

• ACNS0331 – Medulloblastoma
  A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
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  Title A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial Tumor Type SR medulloblastoma Description This trial is a Phase III randomized study designed to reduce the neuro-toxicity of treatment in children diagnosed with medulloblastoma without compromising efficacy by reducing the overall area and dose of radiation therapy given. Major Eligbility Age: 3-22years old histologically confirmed medulloblastoma Exclusion: tumor anaplasia Timing: within 31 days of definitive surgery Clinicaltrials.gov ID NCT00085735

• ACNS0332 – Medulloblastoma/PNET
  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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  Title Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients Tumor Type HR medulloblastoma or sPNET Description This is a Phase III randomized study to determine whether the addition of carboplatin can help improve the radiosensitivity of medulloblastoma. It is also testing whether adding retinoic acid, a medication thought to cause apoptosis in medulloblastoma cells. Major Eligbility Age: 3-22 yrs old Timing: within 31 days of definitive surgery Clinicaltrials.gov ID NCT00392327

• ACNS0333 – ATRT
  Treatment of Atypical Teratoid/Rhabdoid Tumors of the Central Nervous System with Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation
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  Title Treatment of Atypical Teratoid/Rhabdoid Tumors of the Central Nervous System with Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation Tumor Type ATRT Description This is a Phase III non-randomized study that will incoroporate resection, aggressive chemotherapy and early irradiation into treatment. This will be compared against historical controls to study whether this is a superior treatment regimen. Major Eligbility Age: 0-22 mos old Histology: CNS with INI1 gene mutation Timing: within 31 days of definitive surgery Clinicaltrials.gov ID NCT00653068

• ACNS0334 – Medulloblastoma/PNET
  A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate
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  Title A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate Tumor Type infant medulloblastoma Description This is a Phase III randomized trial for children Major Eligbility Age: Histology: High-risk MB Tissue: mandatory submission Timing: within 31 days of definitive surgery Clinicaltrials.gov ID NCT00336024

High-Grade Glioma

• ACNS0822 – High-grade glioma
  A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Newly Diagnosed High Grade Glioma
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  Title A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Newly Diagnosed High Grade Glioma Tumor Type High-grade glioma Description This is a combined study that will examine whether vorinostat, bevacizumab, or temozolomide is the most effective radio-sensitizer in combination with standard surgical and radiotherapy management. Major Eligbility Age: 3-22yo Histology: primary high-grade glioma Exlusions: brainstem glioma, oligodendroglioma Clinicaltrials.gov ID NCT01236560

Ependymoma

• ACNS0831 – Ependymoma
  Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
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  Title Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years Tumor Type Ependymoma Description This Phase III randomized trial will examine whether a short course of pre-radiation chemotherapy can lead to improved surgical resection, and will also study the potential of post-radiation maintenance chemotherapy in attaining better outcomes. Major Eligbility Age: 12mo-21yrs Histology: Tissue submission mandatory Clinicaltrials.gov ID NCT01096368