Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003406
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer
Sponsor:
Cancer Treatment Centers of America
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III trial to study the effectiveness of combining docetaxel ifosfamide and carboplatin followed by peripheral stem cell transplantation in treating patients with refractory cancer
PURPOSE Phase III 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MRMC-CTCA-9711 | None | None | None |
| NCI-V98-1446 | None | None | None |