Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006243
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2000-09-11
Brief Title:
Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Melanoma Vaccines Differentiation Antigen Peptides MART-127-35 Tyrosinase and Gp-100 as Immune Targets
Status:
COMPLETED
Status Verified Date:
2013-01
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 randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells Colony-stimulating factors such as sargramostim increase the number of white blood cells and platelets found in bone marrow or peripheral blood Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the immunological effects of immunization protocols utilizing MART-127-35 MART-127-35 peptide vaccine tyrosinase tyrosinase peptide or gp-100 gp100 antigen peptides suspended in incomplete Freunds adjuvant IFA in the presence of two different concentrations of sargramostim GM-CSF
II Define the safety and toxicity profile of an immunization protocol utilizing varying concentrations of MART-127-35 tyrosinase and gp-100 peptides suspended in IFA in the presence of two different concentrations of GM-CSF
III Collect preliminary data on therapeutic efficacy as it relates to parameters of immune function in patients with stage IV malignant melanoma
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive tyrosinase peptide MART-127-35 peptide vaccine and gp100 antigen admixed in incomplete Freunds adjuvant subcutaneously SC on day 1 of weeks 0 3 6 9 12 and 24
ARM II Patients receive tyrosinase peptide MART-127-35 peptide vaccine and gp100 antigen admixed in incomplete Freunds adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0 3 6 9 12 and 24
ARM III Patients receive tyrosinase peptide MART-127-35 peptide vaccine and gp100 antigen admixed in incomplete Freunds adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0 3 6 9 12 and 24
In all arms treatment may repeat every 3 months for up to 18 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for up to 3 years
I Determine the immunological effects of immunization protocols utilizing MART-127-35 MART-127-35 peptide vaccine tyrosinase tyrosinase peptide or gp-100 gp100 antigen peptides suspended in incomplete Freunds adjuvant IFA in the presence of two different concentrations of sargramostim GM-CSF
II Define the safety and toxicity profile of an immunization protocol utilizing varying concentrations of MART-127-35 tyrosinase and gp-100 peptides suspended in IFA in the presence of two different concentrations of GM-CSF
III Collect preliminary data on therapeutic efficacy as it relates to parameters of immune function in patients with stage IV malignant melanoma
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive tyrosinase peptide MART-127-35 peptide vaccine and gp100 antigen admixed in incomplete Freunds adjuvant subcutaneously SC on day 1 of weeks 0 3 6 9 12 and 24
ARM II Patients receive tyrosinase peptide MART-127-35 peptide vaccine and gp100 antigen admixed in incomplete Freunds adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0 3 6 9 12 and 24
ARM III Patients receive tyrosinase peptide MART-127-35 peptide vaccine and gp100 antigen admixed in incomplete Freunds adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0 3 6 9 12 and 24
In all arms treatment may repeat every 3 months for up to 18 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for up to 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 |
|---|---|---|---|
| CDR0000068171 | REGISTRY | PDQ Physician Data Query | None |
| MC9973 | None | None | None |