Pharmacokinetics of thiotepa in high-dose regimens for autologous hematopoietic stem cell transplant in Japanese patients with pediatric tumors or adult lymphoma.

ABSTRACT:

Purpose

Thiotepa is used in high-dose chemotherapy (HDT) before autologous hematopoietic stem cell transplantation (HSCT) to treat solid tumors and hematological malignancies. This Phase 1 study was conducted to establish the pharmacokinetics (PK) of thiotepa in a Japanese population.

Methods

HDT/HSCT was performed in pediatric patients (≥ 2 years) with solid tumors or brain tumors (thiotepa 200 mg/m²/day IV-infused over 24 h on HSCT Days - 12, - 11, - 5, and - 4 and melphalan 70 mg/m²/day IV-infused over 1 h on Days - 11, - 5, and - 4) and adult patients (≥ 16 years) with malignant lymphoma (thiotepa 200 mg/m²/day 2-h IV-infusion on HSCT Days - 4 and - 3 plus busulfan 0.8 mg/kg 2-h IV-infusion every 6 h from HSCT Days - 8 to - 5). Pharmacoki

SUBMITTER: Kondo E 

PROVIDER: S-EPMC6768914 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature