Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003027
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin Vinblastine Dacarbazine IL-2 and Interferon A-2B Versus Cisplatin Vinblastine Dacarbazine Alone in Patients With Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells Interferon alfa may interfere with the growth of tumor cells It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma
PURPOSE Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery
PURPOSE Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery
Detailed Description:
OBJECTIVES
Compare response rate duration of response and survival rate in patients with metastatic malignant melanoma treated with cisplatin vinblastine and dacarbazine with or without interleukin-2 and interferon alfa-2b
Determine the toxic effects of these regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to performance status 0 vs 1 prior interferon yes vs no and number of involved sites Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4 Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine
Arm II Patients receive treatment as in arm I Patients also receive interleukin 2 IL-2 IV continuously on days 1-4 and interferon alfa-2b subcutaneously SC daily before IL-2 on days 1-4 and after IL-2 on day 5 followed by filgrastim G-CSF SC daily on days 7-16
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 6 weeks every 3 months for 18 months every 6 months for 18 months and then annually for 2 years
PROJECTED ACCRUAL A total of 482 patients will be accrued for this study within 35 years
Compare response rate duration of response and survival rate in patients with metastatic malignant melanoma treated with cisplatin vinblastine and dacarbazine with or without interleukin-2 and interferon alfa-2b
Determine the toxic effects of these regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to performance status 0 vs 1 prior interferon yes vs no and number of involved sites Patients are randomized to one of two treatment arms
Arm I Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4 Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine
Arm II Patients receive treatment as in arm I Patients also receive interleukin 2 IL-2 IV continuously on days 1-4 and interferon alfa-2b subcutaneously SC daily before IL-2 on days 1-4 and after IL-2 on day 5 followed by filgrastim G-CSF SC daily on days 7-16
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 6 weeks every 3 months for 18 months every 6 months for 18 months and then annually for 2 years
PROJECTED ACCRUAL A total of 482 patients will be accrued for this study within 35 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 |
|---|---|---|---|
| SWOG-E3695 | None | None | None |
| E3695 | None | None | None |
| CLB-509802 | None | None | None |