Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT00003406
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining docetaxel, ifosfamide, and carboplatin followed by peripheral stem cell transplantation in treating patients with refractory cancer.
Detailed Description:
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.
Study:
NCT00003406
Study Brief:
Protocol Section:
NCT00003406