Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350597
Status:
COMPLETED
Last Update Posted:
2006-07-11
First Post:
2006-07-10
Brief Title:
GM-CSF as Adjuvant Therapy of Melanoma
Sponsor:
Northern California Melanoma Center
Organization:
Northern California Melanoma Center
Study Overview
Official Title:
Immunologic and Antibody Responses in Patients Receiving GM-CSF Leukine Sargramostim as Adjuvant Therapy of Stage II T4 III and IV Melanoma
Status:
COMPLETED
Status Verified Date:
2006-07
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:
This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor GM-CSF as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence Stage II T4 III and IV
Detailed Description:
This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor GM-CSF as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence Stage II T4 III and IV The immunological responses include serum neopterin levels In a sub-set of study participants additional immunologic testing will be done including monocyte cytotoxicity to a melanoma cell line and phenotypic and functional markers of dendritic and T cell activation in peripheral blood mononuclear cells The clinical end points of the study include safety time to disease recurrence time to disseminated disease and survival Eligible patients are those with high-risk melanoma who are clinically tumor free following surgery Treatment will consist of GM-CSF at 125 gm2 once daily maximum dose 250 g for 14 days followed by 14 days of rest 28 day cycle for 1 year Clinical status will be monitored until death or until the patient has been tumor free for five years whichever event occurs first Immunologic responses will be determined pretreatment at the end of the first 14 days of dosing Day 15 after the 14-day rest period Day 29 and at the end of 14 days of dosing in cycles 6 Day 155 and 13 Day 351 Clinical outcome will be determined according to patient risk group ultra-high risk Stage IIIC or IV versus high-risk Stage II T4 Stage IIIA and Stage IIIB The pilot study will also assess the association of the immunological responses with clinical response and safety by patient risk group
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