Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098553
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2004-12-07
Brief Title:
Everolimus in Treating Patients With Stage IV Melanoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma
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 such as everolimus work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor
PURPOSE This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma
PURPOSE This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus
Secondary
Determine the median overall survival of patients treated with this drug
Determine the clinical benefit rates ie stable disease partial remission and complete response rates in patients treated with this drug
Determine the toxicity profile of this drug in these patients
Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral everolimus once daily for 8 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration
Primary
Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus
Secondary
Determine the median overall survival of patients treated with this drug
Determine the clinical benefit rates ie stable disease partial remission and complete response rates in patients treated with this drug
Determine the toxicity profile of this drug in these patients
Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral everolimus once daily for 8 weeks Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration
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 |
|---|---|---|---|
| CDR0000402871 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02640 | REGISTRY | None | None |