IRB #

IRB00002868

Title

Phase I/II Study of Carboplatin, Melphalan and Etoposide Phosphate in Conjunction with Osmotic Opening of the Blood-Brain Barrier and Delayed Intravenous Sodium Thiosulfate Chemoprotection, in Previously Treated Subjects with Anaplastic Oligodendroglioma or Oligoastrocytoma

Principal Investigator

Edward Neuwelt

Study Purpose

The purpose of this study is to evaluate the safety and tolerability of chemotherapy delivered along with a special technique called blood-brain barrier disruption (BBBD) in patients with anaplastic oligodendroglioma or oligoastrocytoma. The study will also examine the efficacy (one year progression free survival) of the chemotherapy. Participants of this study will be hospitalized for approximately three days every four weeks, to receive chemotherapy. Chemotherapy drugs will include carboplatin (intra-arterial), melphalan (intra-arterial), and etoposide phosphate (intravenous). The three chemotherapy drugs will be administered in conjunction with BBBD. Participants will receive the drug sodium thiosulfate (intra-venous) four and eight hours after carboplatin, in an effort to reduce side effects associated with this chemotherapy regimen. The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

Medical Condition(s)

Brain & Nervous System

Eligibility Criteria

Anaplastic Oligodendroglioma or Oligoastrocytoma
Prior treatment with Temozolomide
Prior consultation with radiation oncology
Aged 18 to 75 years old

Age Range

18 - 75

Healthy Volunteers Needed

No

Duration of Participation

The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

Minors Included

No

Contact

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

Sponsor

NIH Natl Inst of Neuro Disorders & Stroke, Office of Financial Management; Grants Accounting Branch, National Institutes of Health

Recruitment End

Compensation Provided

No