A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.
- Determine the maximum tolerated dose of thiotepa in combination with carboplatin and
topotecan with peripheral blood stem cell transplantation in patients with recurrent or
refractory pediatric solid tumors.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of thiotepa.
Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide
with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection.
Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on
days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF
beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on
day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients
receive 3 courses of therapy.
Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
Patients are followed at 1 and 2 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.
Primary Purpose: Treatment
Douglas Hawkins, MD
Seattle Children's Hospital
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|