Ignite Creation Date:
2024-05-05 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 9:41 AM
Study NCT ID:
NCT00591370
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2007-12-26
Brief Title:
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Temozolomide also known as TMZ is a chemotherapy drug given by mouth It is similar to DTIC the only FDA-approved chemotherapy for melanoma but because temozolomide is given by mouth it can be given daily over a long period of time We think that temozolomidemay work best if it is given every day for 6 weeks at a time Temozolomide given by this extended schedule is experimental although we have found that it is safe and can shrink melanoma in some patients
One big advantage of TMZ is that it is given by mouth instead of by vein This means that it can be given daily over a long period of time rather than off and on like DTIC We think that TMZ may work better if it is given every day for 6 weeks TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients When extended dosing TMZ was given with either thalidomide or long-acting interferon-α about 30 of patients had their tumors shrink We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves
In this study we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage
We also want to learn more about which tumors are more likely to shrink from TMZ treatment We will test samples of your tumor for whether or not a gene called MGMT has been turned on
One big advantage of TMZ is that it is given by mouth instead of by vein This means that it can be given daily over a long period of time rather than off and on like DTIC We think that TMZ may work better if it is given every day for 6 weeks TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients When extended dosing TMZ was given with either thalidomide or long-acting interferon-α about 30 of patients had their tumors shrink We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves
In this study we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage
We also want to learn more about which tumors are more likely to shrink from TMZ treatment We will test samples of your tumor for whether or not a gene called MGMT has been turned on
Detailed Description:
None
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