Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003284
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Lung Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Tandem Autologous Peripheral Blood Stem Cell Transplantation PBSCT After High Dose Paclitaxel Followed by Ifosfamide Carboplatin and Etoposide ICE for the Treatment of Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2000-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating patients with lung cancer
PURPOSE Phase II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating patients with lung cancer
Detailed Description:
OBJECTIVES I Evaluate the response rate of high dose chemotherapy followed by autologous peripheral blood stem cell transplantation in the treatment of lung cancer
OUTLINE Patients undergo stem cell harvesting Patients receive radiation therapy to primary site and metastatic sites if necessary Patients receive a high dose of paclitaxel by 24 hour continuous infusion then stem cells are infused 72 hours later After a 3-4 week recovery period patients receive ifosfamide and carboplatin by daily continuous infusion on days -7 -6 -5 and -4 Etoposide is administered by continuous infusion twice daily on days -7 -6 -5 and -4 Stem cells are again infused on day 0 Filgrastim granulocyte colony-stimulating factor G-CSF begins on day 0 Patients may receive radiotherapy following recovery from chemotherapy Patients are followed weekly for the first 6 months then periodically for at least 2 years
PROJECTED ACCRUAL This study will accrue 30 patients in 3 years
OUTLINE Patients undergo stem cell harvesting Patients receive radiation therapy to primary site and metastatic sites if necessary Patients receive a high dose of paclitaxel by 24 hour continuous infusion then stem cells are infused 72 hours later After a 3-4 week recovery period patients receive ifosfamide and carboplatin by daily continuous infusion on days -7 -6 -5 and -4 Etoposide is administered by continuous infusion twice daily on days -7 -6 -5 and -4 Stem cells are again infused on day 0 Filgrastim granulocyte colony-stimulating factor G-CSF begins on day 0 Patients may receive radiotherapy following recovery from chemotherapy Patients are followed weekly for the first 6 months then periodically for at least 2 years
PROJECTED ACCRUAL This study will accrue 30 patients in 3 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 |
|---|---|---|---|
| NCI-G98-1408 | None | None | None |
| CPMC-IRB-7836 | None | None | None |
| CU-CAMP-017 | None | None | None |