Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014092
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2001-04-10
Brief Title:
Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Sponsor:
Saint Francis Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide GM-CSF IL2 and Interferon Alfa-2b Phase II Trial
Status:
COMPLETED
Status Verified Date:
2004-03
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 Biological therapies such as interleukin-2 and interferon alfa stimulate a persons white blood cells to kill cancer cells or may interfere with the growth of cancer cells Combining chemotherapy with biological therapies may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of temozolomide followed by sargramostim interleukin-2 and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery
PURPOSE Phase II trial to study the effectiveness of temozolomide followed by sargramostim interleukin-2 and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery
Detailed Description:
OBJECTIVES
Determine the response rate time to progression and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim GM-CSF interleukin-2 and interferon alfa
Determine the safety and tolerability of this regimen in this patient population
Determine the changes in quality of life over time in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral temozolomide on days 1-5 and sargramostim GM-CSF interleukin-2 and interferon alfa subcutaneously on days 6-17 Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion
Quality of life is assessed at baseline every 8 weeks during study and then at 1 month after study
Patients are followed at 1 month every 3 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 2 years
Determine the response rate time to progression and survival of patients with unresectable stage IV melanoma treated with temozolomide followed by sargramostim GM-CSF interleukin-2 and interferon alfa
Determine the safety and tolerability of this regimen in this patient population
Determine the changes in quality of life over time in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral temozolomide on days 1-5 and sargramostim GM-CSF interleukin-2 and interferon alfa subcutaneously on days 6-17 Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion
Quality of life is assessed at baseline every 8 weeks during study and then at 1 month after study
Patients are followed at 1 month every 3 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1591 | None | None | None |
| SFMH-BB-IND-5301 | None | None | None |