Phase I/II Study of Intra-arterial Melphalan Given With Intra-arterial Carboplatin, Osmotic Blood-Brain Barrier Disruption and Delayed Otoprotective Sodium Thiosulfate for Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

Inclusion Criteria:

- Subjects with histologically confirmed CNS embryonal tumor (PNET, medulloblastoma,
ATRT, medulloepithelioma, pineoblastoma or ependymoblastoma), or germ cell tumor

- Subjects must have had prior therapy according to the best available therapy as
determined by their primary brain tumor specialist (to include oncology, neurosurgery
and/or radiation oncology) including systemic and/or cranial radiation or
chemotherapy. At least 14 days must have elapsed since completion of cranial
radiotherapy and 28 days since completion of chemotherapy. At least 28 days must have
elapsed since completion of total spine radiotherapy

- Subjects must have a consultation with a radiation oncologist or providers must have
a discussion in the context of Neuro-Oncology Tumor Board within 28 days prior to
start of IA/BBBD chemotherapy to determine the need for radiotherapy prior to or
after IA/BBBD.

- For the phase II portion of the study, subjects must have disease that is evaluable
for response per Section 8.4. Subjects who have had radiation to all sites of
disease are not eligible unless there has been documented radiographic progression of
tumors subsequent to radiation

- Age greater or equal to 1 year and less than 30 years of age

- Baseline laboratory data should be the following:

- GFR greater than 30

- Absolute granulocyte count greater or equal to 1.0 x 103/mm3

- Platelets greater or equal to 100 x 103/mm3

- Creatinine < 1.5

- Total Bilirubin < 2.0

- AST/ALT < 2.5x upper limits of normal

- Karnofsky Performance Status (KPS) must be greater than or equal to 50%

- Subjects or their legal guardian must sign a written informed consent in accordance
with institutional guidelines

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study treatment and for the duration of study treatment.

Exclusion Criteria:

- radiographic signs of excessive intracranial mass effect with associated rapid
neurologic deterioration and/or spinal cord block

- significant risk with general anesthesia

- uncontrolled (over the last 30 days) clinically significant confounding medical
conditions

- pregnant or lactating

- contraindications to carboplatin, melphalan, or STS