Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079144
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2004-03-08
Brief Title:
Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion Peptide Vaccine Plus Montanide ISA-51 and Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen
Status:
COMPLETED
Status Verified Date:
2005-05
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 work in different ways to stop tumor cells from dividing so they stop growing or die Treating a persons lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy Vaccines made from peptides may make the body build an immune response to kill tumor cells Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells Interleukin-2 may stimulate a persons lymphocytes to kill tumor cells
PURPOSE This phase II trial is studying how well lymphocyte-depleting nonmyeloablative not damaging to bone marrow chemotherapy followed by autologous lymphocyte infusion peptide vaccine plus Montanide ISA-51 and interleukin-2 works in treating patients with metastatic melanoma
PURPOSE This phase II trial is studying how well lymphocyte-depleting nonmyeloablative not damaging to bone marrow chemotherapy followed by autologous lymphocyte infusion peptide vaccine plus Montanide ISA-51 and interleukin-2 works in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the clinical tumor regression in patients with metastatic melanoma treated with a lymphocyte-depleting nonmyeloablative preparative chemotherapy regimen followed by autologous lymphocyte infusion ESO-1 peptide vaccination comprising ESO-1157-165 165V and Montanide ISA-51 and interleukin-2
Secondary
Determine the survival of the infused lymphocytes in patients treated with this regimen
Determine the long-term immune status of patients treated with this regimen
OUTLINE Patients are stratified according to type of lymphocyte infusion ESO-1-reactive tumor-infiltrating lymphocytes TIL vs ESO-1 reactive peripheral blood lymphocytes PBL
Autologous lymphocyte collection and expansion Autologous PBL or TIL are collected from patients during leukapheresis or biopsy The cells are sensitized in vitro with ESO-1157-165 165V melanoma antigen and expanded
Lymphocyte-depleting nonmyeloablative preparative chemotherapy Patients receive lymphocyte-depleting nonmyeloablative preparative chemotherapy comprising cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 15-30 minutes on days -5 to -1
Autologous lymphocyte infusion Autologous PBL or TIL are reinfused on day 0 Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 1 and continuing until blood counts recover
ESO-1 peptide vaccination Patients receive ESO-1 peptide vaccination comprising ESO-1157-165 165V peptide emulsified in Montanide ISA-51 SC on days 0-4 11 18 and 25
Interleukin therapy Patients receive interleukin-2 IV over 15 minutes 3 times daily on days 0-4
NOTE Day 0 is 1-4 days after the last dose of fludarabine
Patients achieving stable disease or partial response may receive up to 1 retreatment course Patients with progressive disease after infusion of PBL may receive retreatment with TIL if available
Patients are followed at 4-5 weeks every 3-4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study within 2-3 years
Primary
Determine the clinical tumor regression in patients with metastatic melanoma treated with a lymphocyte-depleting nonmyeloablative preparative chemotherapy regimen followed by autologous lymphocyte infusion ESO-1 peptide vaccination comprising ESO-1157-165 165V and Montanide ISA-51 and interleukin-2
Secondary
Determine the survival of the infused lymphocytes in patients treated with this regimen
Determine the long-term immune status of patients treated with this regimen
OUTLINE Patients are stratified according to type of lymphocyte infusion ESO-1-reactive tumor-infiltrating lymphocytes TIL vs ESO-1 reactive peripheral blood lymphocytes PBL
Autologous lymphocyte collection and expansion Autologous PBL or TIL are collected from patients during leukapheresis or biopsy The cells are sensitized in vitro with ESO-1157-165 165V melanoma antigen and expanded
Lymphocyte-depleting nonmyeloablative preparative chemotherapy Patients receive lymphocyte-depleting nonmyeloablative preparative chemotherapy comprising cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 15-30 minutes on days -5 to -1
Autologous lymphocyte infusion Autologous PBL or TIL are reinfused on day 0 Patients also receive filgrastim G-CSF subcutaneously SC once daily beginning on day 1 and continuing until blood counts recover
ESO-1 peptide vaccination Patients receive ESO-1 peptide vaccination comprising ESO-1157-165 165V peptide emulsified in Montanide ISA-51 SC on days 0-4 11 18 and 25
Interleukin therapy Patients receive interleukin-2 IV over 15 minutes 3 times daily on days 0-4
NOTE Day 0 is 1-4 days after the last dose of fludarabine
Patients achieving stable disease or partial response may receive up to 1 retreatment course Patients with progressive disease after infusion of PBL may receive retreatment with TIL if available
Patients are followed at 4-5 weeks every 3-4 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study within 2-3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-04-C-0104 | None | None | None |
| NCI-6233 | None | None | None |