Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002767
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
GlaxoSmithKline
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cellsVaccines may make the body build an immune response to kill tumor cells It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES I Compare survival following immunotherapy with an allogeneic melanoma vaccine plus interferon alfa-2b IFN-A vs IFN-A alone in patients with metastatic melanoma II Assess the safety and toxicity of immunotherapy with an allogeneic melanoma vaccine plus IFN-A in these patients III Compare the frequencies of durable complete responses in each treatment group IV Compare overall clinical objective response duration of response and time to disease progression in each treatment group V Compare the effects of immunotherapy with an allogeneic melanoma vaccine plus IFN-A vs IFN-A alone on quality of life in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by location of metastatic sites visceral and bone vs nonvisceral and lung and number of metastatic sites 1 vs 2 vs 3 or more Patients are randomized to one of two treatment arms Arm I Patients receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously SQ weekly on weeks 1-5 and 8-12 Interferon alfa IFN-A SQ is administered three times a week beginning on week 4 Patients with responding or stable disease receive vaccine monthly beginning on week 16 IFN-A continues in the absence of disease progression or unacceptable toxicity Arm II Patients receive IFN-A SQ three times a week beginning on week 1 Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed before during and after treatment Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 300 patients will be entered over 2 years
OUTLINE This is a randomized multicenter study Patients are stratified by location of metastatic sites visceral and bone vs nonvisceral and lung and number of metastatic sites 1 vs 2 vs 3 or more Patients are randomized to one of two treatment arms Arm I Patients receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously SQ weekly on weeks 1-5 and 8-12 Interferon alfa IFN-A SQ is administered three times a week beginning on week 4 Patients with responding or stable disease receive vaccine monthly beginning on week 16 IFN-A continues in the absence of disease progression or unacceptable toxicity Arm II Patients receive IFN-A SQ three times a week beginning on week 1 Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed before during and after treatment Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 300 patients will be entered over 2 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 |
|---|---|---|---|
| CORIXA-2885-14 | None | None | None |
| RIR-2885-14 | None | None | None |
| YALE-HIC-8666 | None | None | None |
| NCI-V96-0883 | None | None | None |