A Phase I-II Intensive-Dose Ifosfamide, Carboplatin and Taxotere (IC-T) Combination Chemotherapy Followed by Autologous Stem Cell Rescue for Patients With Refractory Malignancies
OBJECTIVES: I. Evaluate the toxicities, safety, and antitumor activity of intensive high
dose chemotherapy consisting of ifosfamide, carboplatin, and docetaxel followed by
autologous stem cell transplantation in a variety of refractory malignancies.
OUTLINE: This is dose-escalation study of docetaxel. Cohorts of at least 4 patients each
receive escalating doses of docetaxel IV over 11 hours as a continuous infusion 2 times
daily in combination with constant doses of ifosfamide IV over 60 minutes daily and
carboplatin IV over 60 minutes daily on days -6, -5, -4, and -3. On day 0, patients receive
autologous stem cell (or bone marrow) transplantation. If 1 or 2 of 4 patients experience
dose limiting toxicity (DLT), 4 additional patients are entered at the same dose level. If 3
or more of 4 or 8 patients experience DLT, there is no further dose escalation and 6
additional patients are entered at the preceding dose level. The maximum tolerated dose is
defined as the dose level immediately preceding the level that caused DLT in greater than
50% of patients. Patients are followed at 3 and 6 months and then semiannually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study.
Primary Purpose: Treatment
Oscar Francisco Ballester, MD
Cancer Treatment Centers of America
United States: Federal Government
|Midwestern Regional Medical Center||Zion, Illinois 60099|