Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005615
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2000-05-02
Brief Title:
Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
The Florida Melanoma Trial A Phase III Trial of Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma Study Site Coordinating Center
Status:
COMPLETED
Status Verified Date:
2012-09
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 Interferon alfa may interfere with the growth of tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells Combining interferon alfa plus radiation therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of interferon alfa plus radiation therapy in treating patients who have stage III or recurrent melanoma that has been removed by surgery
PURPOSE Phase III trial to study the effectiveness of interferon alfa plus radiation therapy in treating patients who have stage III or recurrent melanoma that has been removed by surgery
Detailed Description:
OBJECTIVES I Determine the effectiveness and toxicity of adjuvant radiotherapy given concurrently with interferon alfa to patients with stage III or recurrent melanoma
OUTLINE This is a multicenter study Patients receive interferon alfa IV over 20 minutes daily for 5 consecutive days a week for 4 weeks Patients then receive radiotherapy on days 2 and 4 and interferon alfa subcutaneously SQ on days 1 3 and 5 for 25 weeks Interferon alfa SQ continues 3 times a week for 10 months in the absence of disease progression or unacceptable toxicity Patients are followed every month for 3 months then every 3 months for 2 years then every six months until year 5 and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 275 years
OUTLINE This is a multicenter study Patients receive interferon alfa IV over 20 minutes daily for 5 consecutive days a week for 4 weeks Patients then receive radiotherapy on days 2 and 4 and interferon alfa subcutaneously SQ on days 1 3 and 5 for 25 weeks Interferon alfa SQ continues 3 times a week for 10 months in the absence of disease progression or unacceptable toxicity Patients are followed every month for 3 months then every 3 months for 2 years then every six months until year 5 and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 275 years
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 |
|---|---|---|---|
| NCI-G00-1750 | OTHER | NCI | None |