Phase I/II Study of High Dose Topotecan, Mitoxantrone and Thiotepa (TMT) Followed by Autologous Stem Cell Transplant in Patients With Recurrent Platinum Resistant Ovarian Cancer
OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of
topotecan, mitoxantrone, and thiotepa given in combination followed by autologous peripheral
blood stem cell transplantation in patients with recurrent or refractory platinum resistant
epithelial ovarian cancer. II. Determine the progression-free survival and overall survival
of these patients after this therapy.
OUTLINE: This is a dose escalation study of topotecan. All patients have peripheral stem
cells collected. Patients then receive topotecan according to an escalating dose schedule,
and mitoxantrone and thiotepa on a fixed dose schedule. Patients receive topotecan by
continuous infusion for 24 hours on days 1-3, mitoxantrone intravenously over 1 hour on days
1-3, and thiotepa intravenously over 4 hours on days 1-3, followed 48 hours later by
infusion of their peripheral stem cells. Patients may receive a second course of
chemotherapy and peripheral stem cell transplantation in the absence of disease progression
and unacceptable toxicity. Dose escalation of topotecan continues in cohorts of 3-6 patients
each until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 or more patients experience dose limiting toxicity. Patients are
followed every week for the first month, then every month for 6 months, every 3 months for 1
year, and then every 6 months.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Primary Purpose: Treatment
Gary Spitzer, MD
Lombardi Cancer Research Center
United States: Federal Government
|Vincent T. Lombardi Cancer Research Center, Georgetown University||Washington, District of Columbia 20007|