Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059475
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2003-04-26
Brief Title:
Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Comparison of Peptide Immunization in Patients at High Risk for Recurrence of Melanoma
Status:
COMPLETED
Status Verified Date:
2012-10
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 study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of melanoma The likelihood of melanoma returning is higher in patients who have melanoma lesions deep in the skin in patients who have had positive lymph nodes and in patients who have had surgery for metastatic disease cancer that has spread beyond the primary site Melanoma tumors produce proteins called glycoprotein 100 gp100 and melanoma-associated antigen recognized by T cells 1 MART-1 Vaccination with specific pieces of these proteins peptides may boost the immune systems fight against the cancer The vaccine injections are mixed with an oil-based substance called Montanide ISA-51 which is intended to increase the immune response to the peptide
Patients 16 years of age and older whose melanoma has been surgically removed and who are currently free of disease may be eligible for this study Candidates will be screened with a physical examination and blood and urine tests An electrocardiogram EKG x-rays and other imaging studies will be done if recent results are not available Some candidates may require heart tests such as a cardiac stress test or echocardiogram or lung function tests In addition all candidates will be tested for human leukocyte antigen HLA tissue type patients must be type human leukocyte antigens HLA-A0201 the type on which this vaccine is based
Participants will be randomly assigned to receive one of four different vaccines to determine which peptides offer the best immunity Each treatment course consists of two injections of the vaccines every 3 weeks for four times The injections are given under the skin of the thigh After every other treatment course every 6 months patients will undergo a series of x-rays and scans to look for tumor The immunizations may continue for up to 12 months as long as the melanoma does not return The injections are given at the National Institutes of Health NIH Clinical Center Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects
Patients will be followed with blood tests every 12 weeks to monitor body functions They will also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells For this procedure blood is drawn through a needle in the arm similar to donating blood The blood goes through a machine that separates out the lymphocytes white blood cells and the rest of the blood is returned through a needle in the other arm Some patients may undergo a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells
Patients whose disease returns during the first course of vaccine therapy will have surgery to remove the tumor and will continue to receive the vaccine treatment Patients whose tumor returns after completing one course of therapy may receive a substance called interleukin-2 IL-2 which can boost immune function against the tumor interleukin-2 IL-2 is given intravenously through a small tube placed in a vein every 8 hours for 4 days This regimen is repeated after 10 to 14 days Those who respond to interleukin-2 IL-2 will have a third course of treatment after 2 months Patients whose disease recurs after treatment will be taken off the study and will be referred back to their referring physician or to another study if an appropriate one is available
Patients 16 years of age and older whose melanoma has been surgically removed and who are currently free of disease may be eligible for this study Candidates will be screened with a physical examination and blood and urine tests An electrocardiogram EKG x-rays and other imaging studies will be done if recent results are not available Some candidates may require heart tests such as a cardiac stress test or echocardiogram or lung function tests In addition all candidates will be tested for human leukocyte antigen HLA tissue type patients must be type human leukocyte antigens HLA-A0201 the type on which this vaccine is based
Participants will be randomly assigned to receive one of four different vaccines to determine which peptides offer the best immunity Each treatment course consists of two injections of the vaccines every 3 weeks for four times The injections are given under the skin of the thigh After every other treatment course every 6 months patients will undergo a series of x-rays and scans to look for tumor The immunizations may continue for up to 12 months as long as the melanoma does not return The injections are given at the National Institutes of Health NIH Clinical Center Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects
Patients will be followed with blood tests every 12 weeks to monitor body functions They will also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect the action of the immune system cells For this procedure blood is drawn through a needle in the arm similar to donating blood The blood goes through a machine that separates out the lymphocytes white blood cells and the rest of the blood is returned through a needle in the other arm Some patients may undergo a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells
Patients whose disease returns during the first course of vaccine therapy will have surgery to remove the tumor and will continue to receive the vaccine treatment Patients whose tumor returns after completing one course of therapy may receive a substance called interleukin-2 IL-2 which can boost immune function against the tumor interleukin-2 IL-2 is given intravenously through a small tube placed in a vein every 8 hours for 4 days This regimen is repeated after 10 to 14 days Those who respond to interleukin-2 IL-2 will have a third course of treatment after 2 months Patients whose disease recurs after treatment will be taken off the study and will be referred back to their referring physician or to another study if an appropriate one is available
Detailed Description:
Human leukocyte antigens HLA-A0201 positive patients at high risk for recurrence of melanoma or completely resected metastatic melanoma will receive immunization with peptides representing human leukocyte antigen HLA-restricted T cell epitopes of the melanoma antigen recognized by T-cells MART-1 or glycoprotein 100 gp100 melanoma antigens emulsified in Montanide ISA-51 or Montanide trademarkTM ISA 51 vegetable grade VG Patients will be randomized to receive one of three different melanoma antigen recognized by T-cells MART-1 peptides or to receive a combination of a melanoma antigen recognized by T-cells MART-1 peptide plus a glycoprotein 100 gp100 peptide This study is designed to evaluate the immunologic effects of the different peptide immunizations
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 |
|---|---|---|---|
| 03-C-0172 | None | None | None |