Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003899
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
High-Dose Consolidation With Escalating Doses of Melphalan and Thiotepa for Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-09
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 bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of melphalan and thiotepa plus bone marrow or peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of melphalan and thiotepa plus bone marrow or peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of melphalan and thiopeta in patients with recurrent or refractory solid tumors II Evaluate the overall survival and response rate in these patients
OUTLINE This is a dose escalation study Patients receive cyclophosphamide IV over 1 hour on day 1 and paclitaxel IV over 4 or 24 hours on day 2 followed by daily filgrastim G-CSF subcutaneously beginning on day 3 and continuing through day 7 or until WBCs are greater than 100000 cellsmm3 Peripheral blood stem cells PBSC or autologous bone marrow is collected on days 5-7 At 30-50 days following mobilization patients receive melphalan IV over 15-60 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2 followed by autologous bone marrow transplantation or PBSC infusion on day 0 Sequential dose escalation of melphalan is followed by sequential dose escalation of thiotepa Dose escalation in cohorts of 5 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 3 of 7 4 of 11 or 5 of 15 patients experience dose limiting toxicity Patients are followed at 60 days and at 12 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 years
OUTLINE This is a dose escalation study Patients receive cyclophosphamide IV over 1 hour on day 1 and paclitaxel IV over 4 or 24 hours on day 2 followed by daily filgrastim G-CSF subcutaneously beginning on day 3 and continuing through day 7 or until WBCs are greater than 100000 cellsmm3 Peripheral blood stem cells PBSC or autologous bone marrow is collected on days 5-7 At 30-50 days following mobilization patients receive melphalan IV over 15-60 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2 followed by autologous bone marrow transplantation or PBSC infusion on day 0 Sequential dose escalation of melphalan is followed by sequential dose escalation of thiotepa Dose escalation in cohorts of 5 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 3 of 7 4 of 11 or 5 of 15 patients experience dose limiting toxicity Patients are followed at 60 days and at 12 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| CDR000006707 | REGISTRY | PDQ | None |
| FHCRC-134300 | None | None | None |
| NCI-H99-0032 | None | None | None |