Embryonal Tumor With Multilayered Rosettes

Eligibility Criteria

• 1. Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes.
• 2. For enrollment, a confirmation of a minimum of 10-20 unstained formalin-fixed paraffin-embedded (FFPE) slides or 1 block (15-20 mg) with tumor content of 40% or greater is required. Anything less must be discussed and approved by the study chairs prior to enrollment.
• 3. Prior Therapy:
• 1. Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.
• 2. Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment.
• 4. Participants must not have received prior radiation for treatment of tumor.
• 5. Participants of any age are eligible.
• 6. Participants should begin induction chemotherapy within 28 days of the most recent definitive surgical procedure. Participants beginning therapy beyond 28 days from surgery, will need to discuss with study chairs.
• 7. Cohort specific eligibility
• 1. Cohort 1: Gross-total resection, Eligible for early radiotherapy (please see age criteria below), and no evidence of metastatic disease.
• 2. Cohort 2: Gross-total resection, high dose chemotherapy (please see age criteria below), and no evidence of metastatic disease.
• 3. Cohort 3A: Metastatic or residual disease, and early radiotherapy.
• 4. Cohort 3B: Metastatic or residual disease, and high dose chemotherapy.
• 5. Radiotherapy Age Criteria (at the time of planned radiation): \>12 months of age for participants with infratentorial tumor OR \>15 months of age for participants with supratentorial tumor. For participants being treated on radiotherapy-containing arms, the legal parent/guardian or patient and the physician must be willing to allow the use of radiotherapy for treatment.
• 8. Performance Score: Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants \<=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• 9. Organ Function Requirements:
• 1. Peripheral absolute neutrophil count (ANC) \> 75,000/mm3
• 2. Platelet count \> 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 72 hours prior to enrollment).
• 10. Adequate Renal Function defined as:
• 11. Adequate Liver Function defined as:
• 1. Total bilirubin \< 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \< 3 x ULN or direct bilirubin \< 1.5 x ULN,
• 2. alanine aminotransferase (ALT) \< 3 x ULN,
• 3. aspartate aminotransferase (AST) \< 3 x ULN,
• 12. Adequate Neurologic Function defined as:
• 13. As chemotherapeutic agents used in this trial are known to be teratogenic, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• 14. Participants must be enrolled on PNOC COMP prior to enrollment on PNOC031 if PNOC COMP is open to accrual at the enrolling institution.
• 15. A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
• 1. Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention
• 2. Participants who are receiving any other tumor directed investigational agents.
• 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
• 4. Uncontrolled intercurrent illness.
• 5. Women of childbearing potential must not be pregnant or breast-feeding.