Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390338
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2006-10-18
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Pawel Kalinski
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Evaluation of Alpha-Type-1 DC-Based and cDC-Based Intralymphatic Vaccines in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2017-09
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:
RATIONALE Vaccines made from a persons dendritic cells mixed with tumor peptides and proteins may help the body build an effective immune response to kill tumor cells Infusing the vaccine directly into the lymphatic system may cause a stronger immune response and kill more tumor cells
PURPOSE This randomized phase I trial is studying the side effects and best dose of two dendritic cell vaccines in treating patients with stage III or stage IV melanoma
PURPOSE This randomized phase I trial is studying the side effects and best dose of two dendritic cell vaccines in treating patients with stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Compare the safety of intralymphatic autologous type-1-polarized dendritic cell vaccine vs autologous mature dendritic cell vaccine loaded with antigenic peptides and proteins in patients with stage III or IV melanoma
Secondary
Determine peripheral blood CD8 and CD4 T-cell responses to HLA-presented melanoma epitopes and autologous tumor cells using interferon gamma and interleukin-5 ELISPOT assay
Compare the delayed-type hypersensitivity DTH responses to these regimens and DTH to autologous tumor lysates in these patients
Compare the DTH response to keyhole limpet hemocyanin and pan-DR epitope PADRE in these patients
Correlate treatment-associated changes in immune response with clinical outcome
OUTLINE This is a randomized open-label dose-escalation study Patients are randomized to 1 of 2 formulations of dendritic cell DC vaccines
Arm I Patients receive intralymphatic autologous type-1-polarized by interleukin-1-beta tumor necrosis factor TNF alfa interferon alfa poly-IC and interferon gamma DC vaccine that has been loaded with tumor-related peptide antigens gp100209-217210M peptide tyrosinase peptide MART-127-35 peptide MAGE-36 and EphA2 and proteins keyhole limpet hemocyanin KLH first course or pan-DR epitope PADRE second course every 6 hours on days 1-4 of weeks 1 and 6
Arm II Patients receive intralymphatic autologous mature by interleukin-1-beta TNF alfa interleukin-6 and prostaglandin E_2 DC vaccine that has been loaded with tumor-related peptide antigens and proteins as in arm I every 6 hours on days 1-4 of weeks 1 and 6
Patients achieving complete response receive 2 more courses of treatment 3 months apart Patients achieving partial response receive up to 10 more courses of treatment 1 month apart in the absence of disease progression or unacceptable toxicity
In each arm cohorts of 4-7 patients receive escalating doses of DC vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 7 patients experience dose-limiting toxicity
Blood samples are obtained at baseline and periodically during and after treatment Samples are examined by immunoenzyme techniques for immunologic measurements
After completion of study therapy patients are followed periodically for 10½ years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Compare the safety of intralymphatic autologous type-1-polarized dendritic cell vaccine vs autologous mature dendritic cell vaccine loaded with antigenic peptides and proteins in patients with stage III or IV melanoma
Secondary
Determine peripheral blood CD8 and CD4 T-cell responses to HLA-presented melanoma epitopes and autologous tumor cells using interferon gamma and interleukin-5 ELISPOT assay
Compare the delayed-type hypersensitivity DTH responses to these regimens and DTH to autologous tumor lysates in these patients
Compare the DTH response to keyhole limpet hemocyanin and pan-DR epitope PADRE in these patients
Correlate treatment-associated changes in immune response with clinical outcome
OUTLINE This is a randomized open-label dose-escalation study Patients are randomized to 1 of 2 formulations of dendritic cell DC vaccines
Arm I Patients receive intralymphatic autologous type-1-polarized by interleukin-1-beta tumor necrosis factor TNF alfa interferon alfa poly-IC and interferon gamma DC vaccine that has been loaded with tumor-related peptide antigens gp100209-217210M peptide tyrosinase peptide MART-127-35 peptide MAGE-36 and EphA2 and proteins keyhole limpet hemocyanin KLH first course or pan-DR epitope PADRE second course every 6 hours on days 1-4 of weeks 1 and 6
Arm II Patients receive intralymphatic autologous mature by interleukin-1-beta TNF alfa interleukin-6 and prostaglandin E_2 DC vaccine that has been loaded with tumor-related peptide antigens and proteins as in arm I every 6 hours on days 1-4 of weeks 1 and 6
Patients achieving complete response receive 2 more courses of treatment 3 months apart Patients achieving partial response receive up to 10 more courses of treatment 1 month apart in the absence of disease progression or unacceptable toxicity
In each arm cohorts of 4-7 patients receive escalating doses of DC vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 7 patients experience dose-limiting toxicity
Blood samples are obtained at baseline and periodically during and after treatment Samples are examined by immunoenzyme techniques for immunologic measurements
After completion of study therapy patients are followed periodically for 10½ years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-2009-00125 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| PCI-UPCI-03-118 | None | None | None |
| NCI-7089 | None | None | None |
| PCI-IRB-0409071 | None | None | None |
| CDR0000504518 | REGISTRY | None | None |