IRB #

IRB00005056

Title

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

Principal Investigator

Edward Neuwelt

Study Purpose

The purpose of this study is to determine the safety and effectiveness of the chemotherapy drugs called carboplatin and melphalan, when they are given into an artery, in patients with malignant brain tumors (called embryonal and germ cell tumors). The carboplatin and melphalan will be given during a procedure called blood-brain barrier disruption (BBBD). Patients also receive a drug called sodium thiosulfate in a vein, in order to protect against carboplatin-induced hearing loss.  Participants will be admitted to the hospital every four weeks for approximately three days. The patient will undergo monthly MRI scans of the head, monthly hearing evaluation, as well as weekly blood tests. The patient will also have memory testing done. Treatment will last for up to 12 months.

Medical Condition(s)

Brain & Nervous System

Eligibility Criteria

*CNS embryonal tumor or germ cell tumor
*1 Year to 30 Years
*Must have had prior therapy (systemic and/or cranial radiation or chemotherapy, neurosurgery and/or radiation oncology)
*At least 28 days must have elapsed since prior chemotherapy or radiotherapy

Age Range

1 - 30

Healthy Volunteers Needed

No

Duration of Participation

Minors Included

Yes

Contact

Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu

Sponsor

NIH/NINDS

Recruitment End

Compensation Provided

No