Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062036
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-06-05
Brief Title:
Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes 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:
Tumor Infiltrating Lymphocytes TIL Cells Transduced With An Interleukin-2 SBIL-2 Gene Following The Administration Of A Nonmyeloablative But Lymphocyte Depleting Regimen in Metastatic Melanoma
Status:
COMPLETED
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 Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different ways to stop tumor cells from dividing so they stop growing or die Inserting the gene for interleukin-2 into a persons tumor infiltrating lymphocytes may make the body build an immune response to kill tumor cells Combining cyclophosphamide and fludarabine with gene-modified tumor cells may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of gene-modified tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and to see how well they work in patients with metastatic melanoma phase I is closed to accrual 32906
PURPOSE This phase III trial is studying the side effects and best dose of gene-modified tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and to see how well they work in patients with metastatic melanoma phase I is closed to accrual 32906
Detailed Description:
OBJECTIVES
Primary
Determine the survival of patients with metastatic melanoma administered interleukin-2 gene-modified tumor infiltrating lymphocytes after cyclophosphamide and fludarabine
Compare survival results with prior Surgery Branch studies using adoptive cell therapy without the interleukin-2 retroviral vector SBIL-2 gene
Secondary
Determine clinical tumor regression in patients administered interleukin-2 gene-modified TIL after cyclophosphamide and fludarabine followed by interleukin-2
Determine the toxicity profile of this regimen in these patients
OUTLINE
Phase I closed to accrual as of 32906
Harvest TIL are harvested transduced with IL-2 gene and expanded in vitro over a period of approximately 4 weeks
Nonmyeloablative preparative regimen chemotherapy Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1
Lymphocyte administration Patients receive IL-2 gene-transduced TIL IV over 20-30 minutes on day 0 They also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0 -5 maximum 15 doses Beginning 1-2 days after lymphocyte administration patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover
Retreatment Patients are re-evaluated every 4-6 weeks Retreatment depends on disease status after each regimen Patients with dose-limiting toxicity do not receive further treatment
No response Patients with stable disease or disease progression after the initial treatment are followed or removed from the study
Partial response Patients with a partial or minor response after the initial treatment may receive retreatment approximately 2-4 weeks later with chemotherapy IL-2 gene-transduced TIL immunization and high-dose IL-2 as above every 4-6 weeks for up to 2 courses provided at least a partial response is documented after each regimen
Complete response Patients with a complete response receive no further treatment
Phase II Patients receive treatment and retreatment as in phase I with the MTD of IL-2 gene-transduced TIL
Patients are followed every 3-6 weeks in the absence disease progression
PROJECTED ACCRUAL A total of 33 patients will be accrued for this study
Primary
Determine the survival of patients with metastatic melanoma administered interleukin-2 gene-modified tumor infiltrating lymphocytes after cyclophosphamide and fludarabine
Compare survival results with prior Surgery Branch studies using adoptive cell therapy without the interleukin-2 retroviral vector SBIL-2 gene
Secondary
Determine clinical tumor regression in patients administered interleukin-2 gene-modified TIL after cyclophosphamide and fludarabine followed by interleukin-2
Determine the toxicity profile of this regimen in these patients
OUTLINE
Phase I closed to accrual as of 32906
Harvest TIL are harvested transduced with IL-2 gene and expanded in vitro over a period of approximately 4 weeks
Nonmyeloablative preparative regimen chemotherapy Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1
Lymphocyte administration Patients receive IL-2 gene-transduced TIL IV over 20-30 minutes on day 0 They also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0 -5 maximum 15 doses Beginning 1-2 days after lymphocyte administration patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover
Retreatment Patients are re-evaluated every 4-6 weeks Retreatment depends on disease status after each regimen Patients with dose-limiting toxicity do not receive further treatment
No response Patients with stable disease or disease progression after the initial treatment are followed or removed from the study
Partial response Patients with a partial or minor response after the initial treatment may receive retreatment approximately 2-4 weeks later with chemotherapy IL-2 gene-transduced TIL immunization and high-dose IL-2 as above every 4-6 weeks for up to 2 courses provided at least a partial response is documented after each regimen
Complete response Patients with a complete response receive no further treatment
Phase II Patients receive treatment and retreatment as in phase I with the MTD of IL-2 gene-transduced TIL
Patients are followed every 3-6 weeks in the absence disease progression
PROJECTED ACCRUAL A total of 33 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 |
|---|---|---|---|
| 03-C-0162 | None | None | None |
| NCI-5855 | None | None | None |
| CDR0000304438 | None | None | None |