Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003895
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide 209-2M Vaccine in HLA-A2 Positive Patients With a gt1mm Melanoma on Initial Biopsy
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This randomized pilot phase II trial studies how well vaccine therapy works in treating human leukocyte antigen class 1 histocompatibility A-2 HLA-A2 positive patients with melanoma Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To define the toxicity of administration of gp100 209-217 210M gp100209-217210M peptide vaccine and the human papillomavirus HPV 16 E712-20 peptide HPV16E712-20 peptide vaccine with adjuvant Montanide ISA-51 incomplete Freunds adjuvant to patients who present with a primary melanoma 1 mm thick
II To measure the T-cell response to the modified self-gp100 209-217 210M peptide and the unmodified parental glycoprotein 100 gp100 peptide
III To measure the T-cell response to the control human leukocyte antigen HLA-A21 restricted cytotoxic T-lymphocyte CTL epitope of papilloma virus HPV16E712-20
IV To determine whether analysis of antigen-specific T-cells using specific HLA-A2peptide tetramers is an effective method for monitoring the immune response of patients undergoing peptide vaccination and to compare it to enzyme-linked immunosorbent spot ELISPOT limiting dilution analysis LDA and measurement of intracellular cytokine production fastimmune
V To determine whether there is a difference between the induction of primary peptide-specific T-cell immune responses to the self gp100 peptide versus the foreign E7 peptide
VI To compare the immune response induced by vaccinating every 2 weeks for 6 months a total of 13 vaccinations vs every 3 weeks for 6 months a total of 9 vaccinations
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive gp100209-217210M peptide vaccine and HPV16E712-20 peptide vaccine mixed with incomplete Freunds adjuvant subcutaneously SC every 2 weeks for 6 months Treatment continues in the absence of disease progression or unacceptable toxicity
ARM B Patients receive gp100209-217210M peptide vaccine and HPV16E712-20 peptide vaccine mixed with incomplete Freunds adjuvant SC every 3 weeks for 6 months Treatment continues in the absence of disease progression or unacceptable toxicity
In both arms patients undergo sentinel lymph node biopsy approximately 10 days after the second vaccination Patients with positive lymph nodes undergo complete lymph node dissection and resume vaccinations
After completion of study treatment patients are followed up every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then yearly thereafter
I To define the toxicity of administration of gp100 209-217 210M gp100209-217210M peptide vaccine and the human papillomavirus HPV 16 E712-20 peptide HPV16E712-20 peptide vaccine with adjuvant Montanide ISA-51 incomplete Freunds adjuvant to patients who present with a primary melanoma 1 mm thick
II To measure the T-cell response to the modified self-gp100 209-217 210M peptide and the unmodified parental glycoprotein 100 gp100 peptide
III To measure the T-cell response to the control human leukocyte antigen HLA-A21 restricted cytotoxic T-lymphocyte CTL epitope of papilloma virus HPV16E712-20
IV To determine whether analysis of antigen-specific T-cells using specific HLA-A2peptide tetramers is an effective method for monitoring the immune response of patients undergoing peptide vaccination and to compare it to enzyme-linked immunosorbent spot ELISPOT limiting dilution analysis LDA and measurement of intracellular cytokine production fastimmune
V To determine whether there is a difference between the induction of primary peptide-specific T-cell immune responses to the self gp100 peptide versus the foreign E7 peptide
VI To compare the immune response induced by vaccinating every 2 weeks for 6 months a total of 13 vaccinations vs every 3 weeks for 6 months a total of 9 vaccinations
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive gp100209-217210M peptide vaccine and HPV16E712-20 peptide vaccine mixed with incomplete Freunds adjuvant subcutaneously SC every 2 weeks for 6 months Treatment continues in the absence of disease progression or unacceptable toxicity
ARM B Patients receive gp100209-217210M peptide vaccine and HPV16E712-20 peptide vaccine mixed with incomplete Freunds adjuvant SC every 3 weeks for 6 months Treatment continues in the absence of disease progression or unacceptable toxicity
In both arms patients undergo sentinel lymph node biopsy approximately 10 days after the second vaccination Patients with positive lymph nodes undergo complete lymph node dissection and resume vaccinations
After completion of study treatment patients are followed up every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then yearly thereafter
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 |
|---|---|---|---|
| R21CA082614 | NIH | CTEP | httpsreporternihgovquickSearchR21CA082614 |
| NCI-2013-02096 | REGISTRY | None | None |
| CDR0000067065 | None | None | None |
| NCI-T98-0081 | None | None | None |
| PPMC-IRB-99-9 | OTHER | None | None |
| 99-9 | OTHER | None | None |
| T98-0081 | OTHER | None | None |