Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303836
Status:
TERMINATED
Last Update Posted:
2013-06-06
First Post:
2006-03-15
Brief Title:
Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Using a Peptide Vaccine With or Without Aldesleukin Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2013-06
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:
This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with metastatic melanoma Vaccines made from peptides may help the body build an effective immune response to kill tumor cells Giving vaccine therapy with interleukin-2 chemotherapy and an autologous white blood cell infusion may be a more effective treatment for metastatic melanoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the ability of gp100 and MART-1 peptide vaccines with or without a high-dose interleukin-2 IL-2 when administered after a nonmyeloablative lymphodepleting preparative regimen and reinfusion of autologous CD25 T-regulatory-depleted lymphocytes to mediate tumor regression in patients with metastatic melanoma
SECONDARY OBJECTIVES
I Determine the generation of antitumor lymphocytes and the rate of repopulation of CD25 T-regulatory cells in patients treated with this regimen
II Determine the toxicity of this treatment regimen
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
ARM I Patients undergo apheresis and in-vitro depletion of T-regulatory cells Patients then receive a nonmyeloablative lymphocyte-depleting preparative regimen comprising cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2 followed by autologous T-regulatory-depleted lymphocytes IV over 20-30 minutes on day 0 Patients receive vaccination with gp100209-217 210M and MART-127-35 peptides emulsified in Montanide ISA-51 subcutaneously SC on days 0-3 20-23 41-44 and 62-65 Patients also receive filgrastim G-CSF SC beginning on day 1 and continuing until blood counts recover
ARM II Patients receive treatment as in arm I Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0-4 beginning after the lymphocyte infusion IL-2 treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 1-3 months
I Determine the ability of gp100 and MART-1 peptide vaccines with or without a high-dose interleukin-2 IL-2 when administered after a nonmyeloablative lymphodepleting preparative regimen and reinfusion of autologous CD25 T-regulatory-depleted lymphocytes to mediate tumor regression in patients with metastatic melanoma
SECONDARY OBJECTIVES
I Determine the generation of antitumor lymphocytes and the rate of repopulation of CD25 T-regulatory cells in patients treated with this regimen
II Determine the toxicity of this treatment regimen
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
ARM I Patients undergo apheresis and in-vitro depletion of T-regulatory cells Patients then receive a nonmyeloablative lymphocyte-depleting preparative regimen comprising cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2 followed by autologous T-regulatory-depleted lymphocytes IV over 20-30 minutes on day 0 Patients receive vaccination with gp100209-217 210M and MART-127-35 peptides emulsified in Montanide ISA-51 subcutaneously SC on days 0-3 20-23 41-44 and 62-65 Patients also receive filgrastim G-CSF SC beginning on day 1 and continuing until blood counts recover
ARM II Patients receive treatment as in arm I Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0-4 beginning after the lymphocyte infusion IL-2 treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 1-3 months
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-P6574 | None | None | None |
| P6574 | None | None | None |
| NCI-06-C-0028 | None | None | None |
| CDR0000459683 | None | None | None |
| NCI-7547 | None | None | None |