Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138229
Status:
TERMINATED
Last Update Posted:
2012-03-29
First Post:
2005-08-29
Brief Title:
Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent Metastatic Melanoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Trial Using Aldesleukin IL-2 Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE An infusion of a patients lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma Drugs such as cyclophosphamide and fludarabine may suppress the immune system so that the patients immune cells allow the infused lymphocytes to work Interleukin-2 may help the lymphocytes kill more tumor cells when they are put back in the body Giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients with refractory or recurrent melanoma
PURPOSE This phase II trial is studying how well giving cyclophosphamide and fludarabine followed by an autologous lymphocyte infusion and interleukin-2 works in treating patients with refractory or recurrent melanoma
Detailed Description:
OBJECTIVES
Primary
Determine tumor regression in patients with metastatic melanoma treated with nonmyeloablative lymphodepleting chemotherapy comprising cyclophosphamide and fludarabine followed by autologous CD25-positive-T-regulatory-cell-depleted lymphocyte reinfusion and high-dose interleukin-2
Secondary
Determine the rate of repopulation of CD25-positive T-regulatory cells in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE
Apheresis and CD25-positive T-regulatory cell depletion Patients undergo 1-2 aphereses to collect peripheral blood mononuclear cells PBMC CD25-positive T-regulatory cells are depleted from the collected PBMC in vitro
Nonmyeloablative lymphodepleting chemotherapy Patients receive cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2
Autologous CD25-positive-T-regulatory-cell-depleted lymphocyte reinfusion Patients receive autologous lymphocytes IV over 20-30 minutes on day 0
Filgrastim G-CSF and high-dose interleukin-2 IL-2 therapy Patients receive G-CSF subcutaneously SC daily beginning on day 0 and continuing until blood counts recover Patients also receive high-dose IL-2 IV over 15 minutes 3 times daily on days 0-4 and 14-18 Patients are reevaluated 4-6 weeks after completion of high-dose IL-2 therapy Patients achieving stable disease or a partial response may receive additional high-dose IL-2 as above for up to 2 retreatment courses in the absence of disease progression or unacceptable toxicity Retreatment begins at least 6 weeks after autologous lymphocyte reinfusion
After completion of study treatment patients are followed at 4-6 weeks and then every 1-2 months thereafter
PROJECTED ACCRUAL A total of 16-29 patients will be accrued for this study within 1-15 years
Primary
Determine tumor regression in patients with metastatic melanoma treated with nonmyeloablative lymphodepleting chemotherapy comprising cyclophosphamide and fludarabine followed by autologous CD25-positive-T-regulatory-cell-depleted lymphocyte reinfusion and high-dose interleukin-2
Secondary
Determine the rate of repopulation of CD25-positive T-regulatory cells in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE
Apheresis and CD25-positive T-regulatory cell depletion Patients undergo 1-2 aphereses to collect peripheral blood mononuclear cells PBMC CD25-positive T-regulatory cells are depleted from the collected PBMC in vitro
Nonmyeloablative lymphodepleting chemotherapy Patients receive cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2
Autologous CD25-positive-T-regulatory-cell-depleted lymphocyte reinfusion Patients receive autologous lymphocytes IV over 20-30 minutes on day 0
Filgrastim G-CSF and high-dose interleukin-2 IL-2 therapy Patients receive G-CSF subcutaneously SC daily beginning on day 0 and continuing until blood counts recover Patients also receive high-dose IL-2 IV over 15 minutes 3 times daily on days 0-4 and 14-18 Patients are reevaluated 4-6 weeks after completion of high-dose IL-2 therapy Patients achieving stable disease or a partial response may receive additional high-dose IL-2 as above for up to 2 retreatment courses in the absence of disease progression or unacceptable toxicity Retreatment begins at least 6 weeks after autologous lymphocyte reinfusion
After completion of study treatment patients are followed at 4-6 weeks and then every 1-2 months thereafter
PROJECTED ACCRUAL A total of 16-29 patients will be accrued for this study within 1-15 years
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 |
|---|---|---|---|
| 05-C-0194 | None | None | None |
| CDR0000440165 | None | None | None |
| NCI-P6573 | None | None | None |