Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324623
Status:
COMPLETED
Last Update Posted:
2012-11-20
First Post:
2006-05-10
Brief Title:
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
Sponsor:
Prof Serge Leyvraz
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Phase I Study of In Vivo Expansion of Melan-AMART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2012-11
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:
RATIONALE Drugs used in chemotherapy such as cyclophosphamide and fludarabine may be used to prepare the body for other treatments such as cellular adoptive immunotherapy Biological therapies such as cellular adoptive immunotherapy may stimulate the immune system in different ways and stop tumor cells from growing Vaccines may help the body build an effective immune response to kill tumor cells Giving cyclophosphamide together with fludarabine followed by biological therapy may be an effective treatment for metastatic melanoma
PURPOSE This phase I trial is studying the side effects of giving cyclophosphamide together with fludarabine followed by cellular adoptive immunotherapy and vaccine therapy in treating patients with metastatic melanoma
PURPOSE This phase I trial is studying the side effects of giving cyclophosphamide together with fludarabine followed by cellular adoptive immunotherapy and vaccine therapy in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the magnitude and duration of the expansion of antigen-specific T-cells present in post-vaccination peripheral blood mononuclear cells and reinfused after immunosuppression in patients with metastatic melanoma
Characterize the T-cell subsets phenotype function T-cell receptor repertoire in these patients
Determine the tumor response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label dose-finding study Patients undergo leukapheresis to collect whole peripheral blood mononuclear cells PBMC Patients are then assigned to 1 of 3 treatment groups
Group 1 closed to accrual as of 582007 Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -3 Patients undergo autologous PBMC infusion on day 0 Patients also receive vaccination comprising Melan-A vaccine emulsified in incomplete Freunds adjuvant IFA subcutaneously SC once every 3 weeks beginning on day 0
Group 2 closed to accrual as of 8152007 Patients receive cyclophosphamide IV at a higher dose than in group 1 on days -7 and -6 and fludarabine IV on days -5 to -3 Patients also receive an autologous PBMC infusion and Melan-A vaccine emulsified in IFA as in group 1
Group 3 Patients receive cyclophosphamide IV at 30 mgkg on days -7 and -6 Patients also receive fludarabine 30 mgm2 IV on days -5 to -3 autologous PBMC infusion on day 0and Melan-A vaccine emulsified in IFA and IMP321 The first 3 patients receive 25 micrograms of IMP321 in the absence of severe 3 or 4 toxicity the dose will be escalated to IMP321 250 micrograms
PROJECTED ACCRUAL A total of 9 patients will be accrued for this study
Determine the magnitude and duration of the expansion of antigen-specific T-cells present in post-vaccination peripheral blood mononuclear cells and reinfused after immunosuppression in patients with metastatic melanoma
Characterize the T-cell subsets phenotype function T-cell receptor repertoire in these patients
Determine the tumor response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label dose-finding study Patients undergo leukapheresis to collect whole peripheral blood mononuclear cells PBMC Patients are then assigned to 1 of 3 treatment groups
Group 1 closed to accrual as of 582007 Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -3 Patients undergo autologous PBMC infusion on day 0 Patients also receive vaccination comprising Melan-A vaccine emulsified in incomplete Freunds adjuvant IFA subcutaneously SC once every 3 weeks beginning on day 0
Group 2 closed to accrual as of 8152007 Patients receive cyclophosphamide IV at a higher dose than in group 1 on days -7 and -6 and fludarabine IV on days -5 to -3 Patients also receive an autologous PBMC infusion and Melan-A vaccine emulsified in IFA as in group 1
Group 3 Patients receive cyclophosphamide IV at 30 mgkg on days -7 and -6 Patients also receive fludarabine 30 mgm2 IV on days -5 to -3 autologous PBMC infusion on day 0and Melan-A vaccine emulsified in IFA and IMP321 The first 3 patients receive 25 micrograms of IMP321 in the absence of severe 3 or 4 toxicity the dose will be escalated to IMP321 250 micrograms
PROJECTED ACCRUAL A total of 9 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 |
|---|---|---|---|
| EU-20607 | None | None | None |
| CHUV-CEPO-ITA-02 | None | None | None |