Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053781
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2003-02-05
Brief Title:
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of Perifosine D-21266 In Previously Untreated Patients With Metastatic Or Recurrent 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 perifosine in treating patients who have metastatic or recurrent malignant melanoma
PURPOSE Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or recurrent malignant melanoma
Detailed Description:
OBJECTIVES
Determine the efficacy of perifosine in terms of response rate in previously untreated patients with metastatic or recurrent malignant melanoma
Assess the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral perifosine daily on days 1-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR or partial response PR receive 2 additional courses after documentation of CR or stable PR ie no further tumor shrinkage
Patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
Determine the efficacy of perifosine in terms of response rate in previously untreated patients with metastatic or recurrent malignant melanoma
Assess the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral perifosine daily on days 1-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR or partial response PR receive 2 additional courses after documentation of CR or stable PR ie no further tumor shrinkage
Patients are followed at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| CDR0000269475 | OTHER | PDQ | None |
| CAN-NCIC-IND156 | OTHER | None | None |