Phase I Clinical Trial of Intravenous L-ascorbic Acid Following Salvage Chemotherapy for Relapsed B-cell non-Hodgkin's Lymphoma

Tokai J Exp Clin Med. 2014 Sep 20;39(3):111-5.

Abstract

Purpose: To determine the safety and the appropriate dose of intravenous l-ascorbic acid (AA) in conjunction with chemotherapy for patients with relapsed lymphoma.

Patients and 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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Ascorbic Acid / administration & dosage*
  • Cyclophosphamide / administration & dosage
  • Cytarabine / administration & dosage
  • Dexamethasone / administration & dosage
  • Etoposide / administration & dosage
  • Female
  • Humans
  • Infusions, Intravenous
  • Lymphoma, B-Cell / drug therapy*
  • Male
  • Middle Aged
  • Rituximab / administration & dosage
  • Salvage Therapy*
  • Treatment Outcome

Substances

  • Cytarabine
  • Rituximab
  • Etoposide
  • Dexamethasone
  • Cyclophosphamide
  • Ascorbic Acid