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
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.
Brain & Nervous System
Anaplastic Oligodendroglioma or Oligoastrocytoma
Prior treatment with Temozolomide
Prior consultation with radiation oncology
Aged 18 to 75 years old
18 - 75
Healthy Volunteers Needed
Duration of Participation
The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.
Edward A Neuwelt, MD 503-494-5626 firstname.lastname@example.org
NIH Natl Inst of Neuro Disorders & Stroke, Office of Financial Management; Grants Accounting Branch, National Institutes of Health