Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005971
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2000-07-05
Brief Title:
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Flavopiridol HMR 1275 NSC 649890 in Patients With Previously Untreated Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2020-04
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 flavopiridol in treating patients who have metastatic malignant melanoma
PURPOSE Phase II trial to study the effectiveness of flavopiridol in treating patients who have metastatic malignant melanoma
Detailed Description:
OBJECTIVES
Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma
Assess the toxicity of this treatment in these patients
Assess the time to progression early progression rate and response duration in these patients when treated with this regimen
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks and then every 3 months until disease progression or death
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma
Assess the toxicity of this treatment in these patients
Assess the time to progression early progression rate and response duration in these patients when treated with this regimen
OUTLINE This is a multicenter study
Patients receive flavopiridol IV over 1 hour on days 1-3 Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks and then every 3 months until disease progression or death
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067955 | OTHER | PDQ | None |
| CAN-NCIC-IND137 | OTHER | None | None |
| NCI-NCIC-137 | OTHER | None | None |