Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003666
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of 6-Hydroxymethylacylfulvene HMAF MGI-114 in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the response rate to 6-hydroxymethylacylfulvene HMAF as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer II Determine the duration of response to this regimen in this patient population III Determine the effect of prior response to chemotherapy on the response to HMAF in these patients IV Determine the survival and failure-free survival of patients treated with HMAF V Evaluate the toxicity profile of HMAF as salvage therapy in these patients
OUTLINE Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days Courses repeat every 28 days Patients with stable or responding disease are treated for a minimum of 6 courses 2 courses beyond optimal response in the absence of unacceptable toxic effects or disease progression Patients are followed at least every 3 months for 1 year then every 6 months until death
PROJECTED ACCRUAL A total of 66 patients 33 for each stratum will be accrued for this study within 12-18 months
OUTLINE Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days Courses repeat every 28 days Patients with stable or responding disease are treated for a minimum of 6 courses 2 courses beyond optimal response in the absence of unacceptable toxic effects or disease progression Patients are followed at least every 3 months for 1 year then every 6 months until death
PROJECTED ACCRUAL A total of 66 patients 33 for each stratum will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| CDR0000066761 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-39805 | None | None | None |