Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027742
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2001-12-07
Brief Title:
Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Temozolomide Temodar and Peglated Interferon Alfa-2B PEGIntron in the Treatment of Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Interferon alfa may interfere with the growth of cancer cells Combining chemotherapy with interferon alfa may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa
Determine the toxicity profile of this regimen in these patients
Determine the duration of disease response and overall survival of patients treated with this regimen
OUTLINE Patients are stratified according to CNS metastases yes vs no
Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 23-61 patients 12-35 without CNS metastases and 11-26 with CNS metastases will be accrued for this study within 18 months
Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa
Determine the toxicity profile of this regimen in these patients
Determine the duration of disease response and overall survival of patients treated with this regimen
OUTLINE Patients are stratified according to CNS metastases yes vs no
Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 23-61 patients 12-35 without CNS metastases and 11-26 with CNS metastases will be accrued for this study within 18 months
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-G01-2031 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069062 | REGISTRY | None | None |