Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012064
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2001-03-03
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Sponsor:
Lisata Therapeutics Inc
Organization:
Lisata Therapeutics Inc
Study Overview
Official Title:
Vaccine Biotherapy of Cancer Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-08
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 cancer cells may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or recurrent melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or recurrent melanoma
Detailed Description:
OBJECTIVES
Determine the safety of immunization with autologous in vitro-treated tumor cells and dendritic cells in combination with sargramostim GM-CSF in patients with stage IV or recurrent melanoma
Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen
Determine the progression-free and overall survival in patients treated with this regimen
Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen
OUTLINE Patients are stratified according to presence of measurable disease at study initiation yes vs no
Patients undergo tumor cell harvest Patients with multiple persistent sites of metastatic disease after harvest may receive systemic therapy biologic therapy andor chemotherapy during tumor cell line expansion over approximately 4 months The tumor cell line is expanded irradiated and treated with interferon gamma
Patients undergo leukapheresis to collect peripheral blood mononuclear cells PBMC to obtain dendritic cells DC The PBMC are treated with sargramostim GM-CSF and interleukin-4 for 7 days to produce DC The DC are then cultured with the treated tumor cells for 18 hours
Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to vaccination and again at week 4 Patients receive vaccine therapy comprising autologous treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3 weeks Vaccine therapy continues monthly for an additional 5 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 4 years
PROJECTED ACCRUAL A total of 30-80 patients will be accrued for this study
Determine the safety of immunization with autologous in vitro-treated tumor cells and dendritic cells in combination with sargramostim GM-CSF in patients with stage IV or recurrent melanoma
Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen
Determine the progression-free and overall survival in patients treated with this regimen
Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen
OUTLINE Patients are stratified according to presence of measurable disease at study initiation yes vs no
Patients undergo tumor cell harvest Patients with multiple persistent sites of metastatic disease after harvest may receive systemic therapy biologic therapy andor chemotherapy during tumor cell line expansion over approximately 4 months The tumor cell line is expanded irradiated and treated with interferon gamma
Patients undergo leukapheresis to collect peripheral blood mononuclear cells PBMC to obtain dendritic cells DC The PBMC are treated with sargramostim GM-CSF and interleukin-4 for 7 days to produce DC The DC are then cultured with the treated tumor cells for 18 hours
Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to vaccination and again at week 4 Patients receive vaccine therapy comprising autologous treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3 weeks Vaccine therapy continues monthly for an additional 5 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 4 years
PROJECTED ACCRUAL A total of 30-80 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-V01-1646 | None | None | None |
| HOAG-VACCINE-MEL | None | None | None |