title: Phase I Clinical Trial of Intravenous L-ascorbic Acid Following Salvage Chemotherapy for Relapsed B-cell non-Hodgkin's Lymphoma.
abstract: OBJECTIVE
  To determine the safety and the appropriate dose of intravenous l-ascorbic acid (AA) in conjunction with chemotherapy for patients with relapsed lymphoma.
  
  
  METHODS
  Patients with relapsed CD20-positive B-cell non-Hodgkin's lymphoma, who were going to receive the CHASER regimen as salvage therapy, were enrolled and treated with escalating doses of AA administered by drip infusion after the 2nd course of the CHASER regimen. The target plasma concentration immediately after AA administration was >15 mM (264 mg/dl).
  
  
  RESULTS
  A serum AA concentration of >15 mM was achieved in 3 sequentially registered patients, all of whom had received a 75 g whole body dose. No obvious adverse drug reaction was observed in the patients. The trial was therefore successfully completed.
  
  
  CONCLUSIONS
  Intravenous AA at a whole body dose of 75 g appears to be safe and sufficient to achieve an effective serum concentration. A phase II trial to evaluate the efficacy of intravenous AA in relapsed/refractory lymphoma patients will now be initiated.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan. hkawada@is.icc.u-tokai.ac.jp.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kawada
authors.forename: Masakazu
authors.initials: M
authors.lastname: Sawanobori
authors.forename: Mitsuyo
authors.initials: M
authors.lastname: Tsuma-Kaneko
authors.forename: Izumi
authors.initials: I
authors.lastname: Wasada
authors.forename: Mitsuki
authors.initials: M
authors.lastname: Miyamoto
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Murayama
authors.forename: Masako
authors.initials: M
authors.lastname: Toyosaki
authors.forename: Makoto
authors.initials: M
authors.lastname: Onizuka
authors.forename: Kosuke
authors.initials: K
authors.lastname: Tsuboi
authors.forename: Kei
authors.initials: K
authors.lastname: Tazume
authors.forename: Yukari
authors.initials: Y
authors.lastname: Shirasugi
authors.forename: Ken
authors.initials: K
authors.lastname: Ohmachi
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ogawa
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kobayashi
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ando
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001205:Ascorbic Acid / Q000008:administration & dosage*; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000069283:Rituximab / Q000008:administration & dosage; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D003561:Cytarabine; D000069283:Rituximab; D005047:Etoposide; D003907:Dexamethasone; D003520:Cyclophosphamide; D001205:Ascorbic Acid