Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004196
Status:
COMPLETED
Last Update Posted:
2014-01-20
First Post:
2000-01-21
Brief Title:
Interferon Alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients With Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy
Status:
COMPLETED
Status Verified Date:
2013-04
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-2b may interfere with the growth of cancer cells
PURPOSE Randomized phase III trial to study the effectiveness of interferon alfa-2b in treating patients who have melanoma with early lymph node metastasis
PURPOSE Randomized phase III trial to study the effectiveness of interferon alfa-2b in treating patients who have melanoma with early lymph node metastasis
Detailed Description:
OBJECTIVES
Compare the efficacy of regional lymphadenectomy with or without adjuvant high-dose interferon alfa-2b on disease-free survival and overall survival of patients with invasive cutaneous melanoma with early or submicroscopic sentinel lymph node metastasis detected by histology or immunohistochemistry or by polymerase chain reaction PCR
Compare the effect of lymphadenectomy vs observation on disease-free survival and overall survival of patients with submicroscopic sentinel lymph node metastasis detected only by PCR
Determine the recurrence rate and survival of patients with submicroscopic sentinel lymph node metastasis detected only by PCR
Determine the positive and negative predictive value of reverse transcriptase PCR analysis of sentinel lymph nodes and peripheral blood to identify patients at risk for recurrence and death
OUTLINE This is a randomized multicenter study Patients in the randomized portions of Protocols A and B are stratified according to tumor thickness 1-2 mm vs 3-4 mm vs greater than 4 mm and tumor ulceration yes vs no
All patients undergo wide local tumor excision with lymphatic mapping and sentinel node biopsy Patients with tumors with ambiguous drainage patterns undergo lymphoscintigraphy prior to tumor excision Patients with evidence of metastatic melanoma in the sentinel nodes by routine histology serial sectioning or immunohistochemistry and who have undergone a prior regional lymph node dissection proceed to protocol A
Protocol A Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms
Arm I Patients receive adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks then subcutaneously 3 times a week for 48 weeks
Arm II Patients undergo observation Patients with metastases in more than one sentinel node with evidence of extracapsular extension or metastasis in any nonsentinel node receive adjuvant high-dose interferon alfa-2b as in arm I
Patients with no evidence of sentinel nodes metastases by routine histology serial sectioning and immunohistochemistry and are negative by polymerase chain reaction PCR analysis are observed
Protocol B Patients with positive sentinel nodes by PCR analysis are randomized to one of three treatment arms
Arm I Patients undergo observation
Arm II Patients undergo lymph node dissection
Arm III Patients undergo lymph node dissection followed by adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks
Patients are followed every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 3000 patients will be accrued for this study within 5 years
Compare the efficacy of regional lymphadenectomy with or without adjuvant high-dose interferon alfa-2b on disease-free survival and overall survival of patients with invasive cutaneous melanoma with early or submicroscopic sentinel lymph node metastasis detected by histology or immunohistochemistry or by polymerase chain reaction PCR
Compare the effect of lymphadenectomy vs observation on disease-free survival and overall survival of patients with submicroscopic sentinel lymph node metastasis detected only by PCR
Determine the recurrence rate and survival of patients with submicroscopic sentinel lymph node metastasis detected only by PCR
Determine the positive and negative predictive value of reverse transcriptase PCR analysis of sentinel lymph nodes and peripheral blood to identify patients at risk for recurrence and death
OUTLINE This is a randomized multicenter study Patients in the randomized portions of Protocols A and B are stratified according to tumor thickness 1-2 mm vs 3-4 mm vs greater than 4 mm and tumor ulceration yes vs no
All patients undergo wide local tumor excision with lymphatic mapping and sentinel node biopsy Patients with tumors with ambiguous drainage patterns undergo lymphoscintigraphy prior to tumor excision Patients with evidence of metastatic melanoma in the sentinel nodes by routine histology serial sectioning or immunohistochemistry and who have undergone a prior regional lymph node dissection proceed to protocol A
Protocol A Patients with metastasis in a single sentinel node with no evidence of extracapsular extension and no metastatic disease in nonsentinel nodes are randomized to 1 of 2 treatment arms
Arm I Patients receive adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks then subcutaneously 3 times a week for 48 weeks
Arm II Patients undergo observation Patients with metastases in more than one sentinel node with evidence of extracapsular extension or metastasis in any nonsentinel node receive adjuvant high-dose interferon alfa-2b as in arm I
Patients with no evidence of sentinel nodes metastases by routine histology serial sectioning and immunohistochemistry and are negative by polymerase chain reaction PCR analysis are observed
Protocol B Patients with positive sentinel nodes by PCR analysis are randomized to one of three treatment arms
Arm I Patients undergo observation
Arm II Patients undergo lymph node dissection
Arm III Patients undergo lymph node dissection followed by adjuvant high-dose interferon alfa-2b IV 5 days a week for 4 weeks
Patients are followed every 3 months for 2 years every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 3000 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| RPCI-DS-99-14 | None | None | None |
| UAB-9735 | None | None | None |
| UAB-F970925009 | None | None | None |
| NCI-G99-1654 | None | None | None |