Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096382
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2004-11-09
Brief Title:
Cyclophosphamide Fludarabine and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy Autologous Stem Cell Transplantation and Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Total Body Irradiation and Reconstitution With CD34 Cells
Status:
COMPLETED
Status Verified Date:
2015-09
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 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 Radiation therapy uses high-energy x-rays to damage tumor cells Biological therapies such as cellular adoptive immunotherapy work in different ways to stimulate the immune system and stop tumor cells from growing Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy Interleukin-2 may stimulate a persons lymphocytes to kill tumor cells Combining chemotherapy radiation therapy and biological therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy autologous stem cell transplant and interleukin-2 works in treating patients with metastatic melanoma
PURPOSE This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy autologous stem cell transplant and interleukin-2 works in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine complete clinical tumor regression in patients with metastatic melanoma treated with a myeloablative lymphoid-depleting preparative regimen comprising cyclophosphamide fludarabine and total body irradiation followed by autologous tumor-reactive tumor-infiltrating lymphocyte infusion autologous CD34 stem cell transplantation and low-dose or high-dose interleukin-2
Evaluate the safety of this regimen in these patients
Secondary
Determine the survival of the infused lymphocytes by analyzing the sequence of the variable region of the T-cell receptor or flow cytometry in patients treated with this regimen
OUTLINE
Autologous stem cell collection Patients receive filgrastim G-CSF subcutaneously SC twice daily for 8 days Beginning on day 5 of G-CSF patients undergo apheresis daily for up to 3 days Patients may receive 1 additional course of G-CSF and apheresis or use stem cells stored from a prior stem cell harvest in order to obtain an adequate number of cells
Lymphocyte-depleting myeloablative preparative regimen Patients receive cyclophosphamide intravenous IV over 1 hour on days -5 and -6 and fludarabine IV over 15-30 minutes on days -6 to -2 Patients also undergo total body irradiation on day -1
Autologous lymphocyte infusion Patients receive autologous tumor-reactive tumor-infiltrating lymphocytes IV over 20-30 minutes on day 0 followed by G-CSF SC once daily until blood counts recover
Autologous stem cell transplantation Patients receive autologous CD34 stem cells IV on day 2
Interleukin therapy Patients are assigned to 1 of 2 cohorts depending on whether they have received prior high-dose interleukin-2 IL-2
Cohort 1 patients who received prior high-dose IL-2 Beginning on day 0 patients receive high-dose IL-2 IV over 15 minutes 3 times daily for up to 5 days maximum of 15 doses
Cohort 3 patients who have not received prior high-dose IL-2 Patients receive treatment as in cohort 1
NOTE Day 0 is 1-4 days after the last dose of fludarabine
Patients are evaluated at 4-6 weeks
PROJECTED ACCRUAL A total of 116 patients will be accrued for this study
Primary
Determine complete clinical tumor regression in patients with metastatic melanoma treated with a myeloablative lymphoid-depleting preparative regimen comprising cyclophosphamide fludarabine and total body irradiation followed by autologous tumor-reactive tumor-infiltrating lymphocyte infusion autologous CD34 stem cell transplantation and low-dose or high-dose interleukin-2
Evaluate the safety of this regimen in these patients
Secondary
Determine the survival of the infused lymphocytes by analyzing the sequence of the variable region of the T-cell receptor or flow cytometry in patients treated with this regimen
OUTLINE
Autologous stem cell collection Patients receive filgrastim G-CSF subcutaneously SC twice daily for 8 days Beginning on day 5 of G-CSF patients undergo apheresis daily for up to 3 days Patients may receive 1 additional course of G-CSF and apheresis or use stem cells stored from a prior stem cell harvest in order to obtain an adequate number of cells
Lymphocyte-depleting myeloablative preparative regimen Patients receive cyclophosphamide intravenous IV over 1 hour on days -5 and -6 and fludarabine IV over 15-30 minutes on days -6 to -2 Patients also undergo total body irradiation on day -1
Autologous lymphocyte infusion Patients receive autologous tumor-reactive tumor-infiltrating lymphocytes IV over 20-30 minutes on day 0 followed by G-CSF SC once daily until blood counts recover
Autologous stem cell transplantation Patients receive autologous CD34 stem cells IV on day 2
Interleukin therapy Patients are assigned to 1 of 2 cohorts depending on whether they have received prior high-dose interleukin-2 IL-2
Cohort 1 patients who received prior high-dose IL-2 Beginning on day 0 patients receive high-dose IL-2 IV over 15 minutes 3 times daily for up to 5 days maximum of 15 doses
Cohort 3 patients who have not received prior high-dose IL-2 Patients receive treatment as in cohort 1
NOTE Day 0 is 1-4 days after the last dose of fludarabine
Patients are evaluated at 4-6 weeks
PROJECTED ACCRUAL A total of 116 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 |
|---|---|---|---|
| CDR0000393480 | None | None | None |
| 04-C-0288 | None | None | None |
| NCI-7025 | None | None | None |
| NCI-PRMC-P6273 | None | None | None |