Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01079741
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2010-03-02
Brief Title:
Safety Study of Adjuvant Vaccine to Treat Melanoma Patients
Sponsor:
Nina Bhardwaj
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Phase IPhase II Open Label Study of the TLR3 Agonist Poly-ICLC as an Adjuvant for NY-ESO-1 Protein Vaccination With or Without Montanide ISA-51 VG in Patients With High Risk Melanoma in Complete Clinical Remission
Status:
COMPLETED
Status Verified Date:
2017-11
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:
The incidence of melanoma is increasing with an estimated incidence of 59940 cases and an annual death rate of 8110 in 2007 Although patients diagnosed with early stage disease have an excellent clinical outcome patients diagnosed with advanced or recurrent disease continue to have a high mortality rate even with initial optimal surgical resection Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate Immunotherapy has long been recognized as a potential therapy for melanoma the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease
Detailed Description:
This is a Phase I open label dose escalation study of the TLR3 agonist Poly-ICLC as an adjuvant for NY-ESO-1 protein vaccination in patients with high risk melanoma in clinical complete remission cCr followed by a randomized Phase II component in which patients will be randomized to subcutaneous vaccination of NY-ESO-1 protein with Poly-ICLC alone dose TBD Arm A or with NY-ESO-1 protein Poly-ICLC dose TBD and Montanide ISA-51 VG Montanide Arm B
Patients with histological confirmed malignant melanoma AJCC Stages IIB IIC III or IV who are in complete clinical remission cCr but at high risk of disease recurrence will be eligible for enrollment regardless of whether antigen expression in the autologous tumor can be demonstrated by either PCR or immunohistochemistry
Primary Objectives
Phase I To define the safety of subcutaneous vaccination with NY-ESO-1 protein Montanide and escalating doses of Poly-ICLC
Phase II To evaluate the induction of humoral and T cell CD4 and CD8 immunity to subcutaneous vaccination with NY-ESO-1 protein in combination with Poly-ICLC when given with or without Montanide
Exploratory analyses
Evaluation of primary tumor expression of NY-ESO-1 by IHC or RT-PCR
Histologic quantitation of original tumor TILs tumor infiltrating lymphocytes CD3 cells evaluation of mitotic index and correlation of this data with immunologic response
Correlation of NY-ESO-1 specific T cell responses with HLA type
Investigation of polymorphisms for TLR3 through germline SNP analysis
Clinical Outcome Time to Progression reported descriptively
Skin section analysis of proteinadjuvant treated sites for immune cell infiltration and gene expression analysis
Patients with histological confirmed malignant melanoma AJCC Stages IIB IIC III or IV who are in complete clinical remission cCr but at high risk of disease recurrence will be eligible for enrollment regardless of whether antigen expression in the autologous tumor can be demonstrated by either PCR or immunohistochemistry
Primary Objectives
Phase I To define the safety of subcutaneous vaccination with NY-ESO-1 protein Montanide and escalating doses of Poly-ICLC
Phase II To evaluate the induction of humoral and T cell CD4 and CD8 immunity to subcutaneous vaccination with NY-ESO-1 protein in combination with Poly-ICLC when given with or without Montanide
Exploratory analyses
Evaluation of primary tumor expression of NY-ESO-1 by IHC or RT-PCR
Histologic quantitation of original tumor TILs tumor infiltrating lymphocytes CD3 cells evaluation of mitotic index and correlation of this data with immunologic response
Correlation of NY-ESO-1 specific T cell responses with HLA type
Investigation of polymorphisms for TLR3 through germline SNP analysis
Clinical Outcome Time to Progression reported descriptively
Skin section analysis of proteinadjuvant treated sites for immune cell infiltration and gene expression analysis
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