Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002669
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
TREATMENT OF METASTATIC MELANOMA WITH DTIC CDDP AND IFN ALPHA WITH OR WITHOUT IL-2 A RANDOMIZED PHASE III TRIAL
Status:
COMPLETED
Status Verified Date:
2012-06
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 the cancer cells Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells It is not yet known which treatment regimen is more effective in treating melanoma
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa dacarbazine cisplatin and interleukin-2
Assess toxicity overall response rate and response duration in these patients when treated with this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to center Patients are randomized to one of two treatment arms
Arm I Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3 Patients also receive interferon alfa subcutaneously SQ on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9 Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses Patients then receive treatment as in arm I for a maximum of 4 courses
Patients are followed every 2 months for 6 months then every 3 months thereafter
PROJECTED ACCRUAL A total of 42-90 patients will be accrued for this study
Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa dacarbazine cisplatin and interleukin-2
Assess toxicity overall response rate and response duration in these patients when treated with this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to center Patients are randomized to one of two treatment arms
Arm I Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3 Patients also receive interferon alfa subcutaneously SQ on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9 Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses Patients then receive treatment as in arm I for a maximum of 4 courses
Patients are followed every 2 months for 6 months then every 3 months thereafter
PROJECTED ACCRUAL A total of 42-90 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-18951 | None | None | None |