Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-31 @ 3:15 AM
Study NCT ID:
NCT00068666
Status:
TERMINATED
Last Update Posted:
2016-12-15
First Post:
2003-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
Status:
TERMINATED
Status Verified Date:
2016-12
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 temozolomide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.
Detailed Description:
OBJECTIVES:
Primary
* Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of the central nervous system treated with temozolomide and radiotherapy.
Secondary
* Determine the safety of this regimen in these patients.
* Determine the survival of patients treated with this regimen.
* Determine the effect of this regimen on performance status and mental status of these patients.
* Determine the response of extra-cranial disease in patients treated with this regimen.
OUTLINE: Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 18-41 patients will be accrued for this study within 13-30 months.
Primary
* Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of the central nervous system treated with temozolomide and radiotherapy.
Secondary
* Determine the safety of this regimen in these patients.
* Determine the survival of patients treated with this regimen.
* Determine the effect of this regimen on performance status and mental status of these patients.
* Determine the response of extra-cranial disease in patients treated with this regimen.
OUTLINE: Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 18-41 patients will be accrued for this study within 13-30 months.
Study Oversight
Has Oversight DMC:
False
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?: