Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002854
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
1999-11-01
Brief Title:
High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN CYCLOPHOSPHAMIDE ETOPOSIDE AND IFOSFAMIDE CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT
Status:
COMPLETED
Status Verified Date:
2015-08
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 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 combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES
Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide cisplatin and cyclophosphamide followed by ifosfamide carboplatin and paclitaxel IC-T each administered with filgrastim G-CSF and autologous stem cell support to patients with advanced carcinomas
Describe the toxicity of these high dose chemotherapy regimens
Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen
Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion
Determine the disposition of carboplatin administered in the IC-T regimen
OUTLINE At least 4 weeks prior to chemotherapy patients undergo stem cell collection following filgrastim G-CSF mobilization Sufficient stem cells to support 2 courses of chemotherapy are required Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate
Patients then receive high dose cisplatin etoposide and cyclophosphamide over 10 days followed the next day by infusion of one fourth of the allotted stem cells with the remaining allotment infused 2 days later G-CSF is given for granulocyte support
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy stable and responding patients receive high dose paclitaxel carboplatin and ifosfamide over 5 days followed 2 days later with one-fourth of the allotted stem cells with the remaining allotment infused the following day G-CSF is given for granulocyte support Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined
Patients are followed monthly for 1 year every 3 months for 1 year then as needed at the physicians discretion for at least 5 years
PROJECTED ACCRUAL Three to six patients will be entered at each dose of paclitaxel studied
Evaluate the feasibility of administering 2 courses of high dose chemotherapy consisting of etoposide cisplatin and cyclophosphamide followed by ifosfamide carboplatin and paclitaxel IC-T each administered with filgrastim G-CSF and autologous stem cell support to patients with advanced carcinomas
Describe the toxicity of these high dose chemotherapy regimens
Define the maximum tolerated dose of paclitaxel deliverable in this high dose regimen
Describe the pharmacokinetics of escalating doses of paclitaxel given as a 24-hour continuous infusion
Determine the disposition of carboplatin administered in the IC-T regimen
OUTLINE At least 4 weeks prior to chemotherapy patients undergo stem cell collection following filgrastim G-CSF mobilization Sufficient stem cells to support 2 courses of chemotherapy are required Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate
Patients then receive high dose cisplatin etoposide and cyclophosphamide over 10 days followed the next day by infusion of one fourth of the allotted stem cells with the remaining allotment infused 2 days later G-CSF is given for granulocyte support
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy stable and responding patients receive high dose paclitaxel carboplatin and ifosfamide over 5 days followed 2 days later with one-fourth of the allotted stem cells with the remaining allotment infused the following day G-CSF is given for granulocyte support Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined
Patients are followed monthly for 1 year every 3 months for 1 year then as needed at the physicians discretion for at least 5 years
PROJECTED ACCRUAL Three to six patients will be entered at each dose of paclitaxel studied
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 |
|---|---|---|---|
| CDR0000065102 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-94098 | None | None | None |
| NCI-V96-1042 | None | None | None |