Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002882
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
1999-11-01
Brief Title:
Interferon Alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Adjuvant Therapy for Melanoma Patients With Regional Lymph Node Metastases With Interferon Alfa-2B vs Biochemotherapy Using Cisplatin Vinblastine DTIC Interferon Plus IL-2
Status:
COMPLETED
Status Verified Date:
2011-12
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 Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma
Detailed Description:
OBJECTIVES
Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b IFN-A administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin vinblastine DTIC IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected
Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin vinblastine DTIC IFN-A and IL-2 and their effect on the quality of life
Determine the prognostic value of detection of melanoma cells in the peripheral blood using RTPCR for tyrosinase mRNA
OUTLINE This is a randomized study All patients are stratified according to prognostic factors
Patients are randomly allocated to 1 of 2 treatment options Treatment 1 uses interferon alfa-2b IFN-A therapy and treatment 2 includes adjuvant biochemotherapy
Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules
Schedule A IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks
Schedule B Subcutaneous IFN-A 3 times a week for 52 weeks Adjuvant biochemotherapy begins immediately after registration on the study Cisplatin is given IV on days 1-4 vinblastine is given IVPB on days 1-4 dacarbazine DTIC is given IVPB on day 1 IFN-A is given subcutaneously on days 1-5 IL-2 is given by continuous infusion for a total of 96 hours on days 1-4 Each course of therapy is repeated every 21 days for 4 courses Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy
PROJECTED ACCRUAL A total of 200 patients 100 patients in each arm will be entered
Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b IFN-A administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin vinblastine DTIC IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected
Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin vinblastine DTIC IFN-A and IL-2 and their effect on the quality of life
Determine the prognostic value of detection of melanoma cells in the peripheral blood using RTPCR for tyrosinase mRNA
OUTLINE This is a randomized study All patients are stratified according to prognostic factors
Patients are randomly allocated to 1 of 2 treatment options Treatment 1 uses interferon alfa-2b IFN-A therapy and treatment 2 includes adjuvant biochemotherapy
Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules
Schedule A IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks
Schedule B Subcutaneous IFN-A 3 times a week for 52 weeks Adjuvant biochemotherapy begins immediately after registration on the study Cisplatin is given IV on days 1-4 vinblastine is given IVPB on days 1-4 dacarbazine DTIC is given IVPB on day 1 IFN-A is given subcutaneously on days 1-5 IL-2 is given by continuous infusion for a total of 96 hours on days 1-4 Each course of therapy is repeated every 21 days for 4 courses Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy
PROJECTED ACCRUAL A total of 200 patients 100 patients in each arm will be entered
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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-ID-95196 | OTHER | None | None |
| MDA-DM-95196 | OTHER | None | None |
| NCI-G96-1089 | None | None | None |
| CDR0000065188 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |