drugset
drugset / Trial / NCT01505569

Auto Transplant for High Risk or Relapsed Solid or CNS Tumors

NCT01505569 ↗

Completed 44 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelOther

Summary

This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood stem cell transplant will be given for 3 cycles.

Timeline

Start
2011-10-20
Primary completion
2024-02-01
Completion
2024-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 2-MERCAPTOETHANESULFONIC ACID Small molecule 1.8 g Intravenous
Subject 2-MERCAPTOETHANESULFONIC ACID Small molecule 2000 mg Intravenous
Subject Busulfan Small molecule 1.1 mg/kg Intravenous
Subject Carboplatin Small molecule 7 unknown Intravenous
Subject Carboplatin Small molecule 8 unknown Intravenous
Subject Carboplatin Small molecule 17 mg/kg Intravenous
Subject Carboplatin Small molecule 510 mg/m2 Intravenous
Subject Etoposide Small molecule 8.3 mg/kg Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous
Subject Etoposide Small molecule 250 mg/m2 Intravenous
Subject Etoposide Small molecule 400 mg/m2 Intravenous
Subject Ifosfamide Small molecule 1.8 g Intravenous
Subject Ifosfamide Small molecule 2000 mg Intravenous
Subject Melphalan Small molecule 50 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Subject Thiotepa Other / unclassified 10 mg/kg Intravenous
Subject Thiotepa Other / unclassified 250 mg/m2 Intravenous
Subject Thiotepa Other / unclassified 300 mg/m2 Intravenous
Background G-CSF Unknown 5 ug/kg Subcutaneous
Background G-CSF Unknown 10 ug/kg Subcutaneous
Background G-CSF Unknown 15 ug/kg Subcutaneous
Background Levetiracetam Other / unclassified 10 mg/kg —
Background Lorazepam Small molecule 0.02 mg/kg Oral
Background Lorazepam Small molecule 0.05 mg/kg Oral
Background Ursodeoxycholic Acid Small molecule 150 mg/m2 Oral

Indications

Ewing sarcoma atypical teratoid rhabdoid tumor germ cell tumor hepatoblastoma kidney neoplasm medulloblastoma primary brain neoplasm retinoblastoma rhabdomyosarcoma supratentorial primitive neuroectodermal tumor