Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006237
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-09-11
Brief Title:
S0008 Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin Vinblastine DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma
Status:
COMPLETED
Status Verified Date:
2015-03
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 cancer cells 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 It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin vinblastine and dacarbazine plus interleukin-2 in treating patients who have melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin vinblastine and dacarbazine plus interleukin-2 in treating patients who have melanoma
Detailed Description:
OBJECTIVES
Compare the overall survival and disease-free survival of patients with high-risk melanoma treated with interferon alfa vs cisplatin vinblastine and dacarbazine plus interferon alfa and interleukin-2
Compare the toxic effects of these treatment regimens in these patients
Determine the relationship between minimal residual disease MRD status at 12 weeks and 52 weeks and overall survival of patients treated with these regimens
Compare the effects of these treatment regimens on the MRD status of these patients
Determine the relationship between clinical characteristics number of involved lymph nodes ulcerated primary and extracapsular extension and MRD in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to nodal status N1 or N2 vs N3 degree of lymph node involvement micrometastases only vs any macrometastases including satellitein-transit metastases and ulceration of the primary tumor yes vs no vs unknown primary Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously SC on days 1 3 and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4 Patients also receive dacarbazine IV over 1 hour on day 1 interleukin-2 IV over 96 hours on days 1-4 and interferon alfa SC on days 1-5 8 10 and 12 In addition patients receive filgrastim G-CSF SC on days 6-15 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 410 patients 205 per treatment arm will be accrued for this study within 3 years
Compare the overall survival and disease-free survival of patients with high-risk melanoma treated with interferon alfa vs cisplatin vinblastine and dacarbazine plus interferon alfa and interleukin-2
Compare the toxic effects of these treatment regimens in these patients
Determine the relationship between minimal residual disease MRD status at 12 weeks and 52 weeks and overall survival of patients treated with these regimens
Compare the effects of these treatment regimens on the MRD status of these patients
Determine the relationship between clinical characteristics number of involved lymph nodes ulcerated primary and extracapsular extension and MRD in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to nodal status N1 or N2 vs N3 degree of lymph node involvement micrometastases only vs any macrometastases including satellitein-transit metastases and ulceration of the primary tumor yes vs no vs unknown primary Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously SC on days 1 3 and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4 Patients also receive dacarbazine IV over 1 hour on day 1 interleukin-2 IV over 96 hours on days 1-4 and interferon alfa SC on days 1-5 8 10 and 12 In addition patients receive filgrastim G-CSF SC on days 6-15 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 410 patients 205 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| COG-S0008 | OTHER | COG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |
| S0008 | OTHER | None | None |
| CALGB-500002 | OTHER | None | None |
| ECOG-S0008 | OTHER | None | None |