Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091143
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2004-09-07
Brief Title:
Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma
Sponsor:
Providence Cancer Center Earle A Chiles Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide gp100209-217210M Montanide ISA 51 and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2009-08
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 fludarabine work in different ways to stop tumor cells from dividing so they stop growing or die Vaccines made from peptides may make the body build an immune response to kill tumor cells Infusions of a persons white blood cells may be able to replace immune cells that were destroyed by chemotherapy Combining fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells
PURPOSE This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma
PURPOSE This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide gp100209-217210M Montanide ISA-51 and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma
Determine the induction of antigen-specific T-cell responses in patients treated with this regimen
Determine the kinetics and duration of immune response in patients treated with this regimen
Compare the immunologic effects of this regimen in these patients with historical results
Secondary
Compare 2 different dosing schedules of fludarabine in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine in these patients
OUTLINE This is a pilot randomized study Patients are randomized to 1 of 2 treatment arms
Within 2 weeks before the start of fludarabine all patients undergo leukapheresis over 4-6 hours for the collection of peripheral blood mononuclear cells PBMCs
Arm I Patients receive fludarabine IV over 30 minutes on days 1-5
Arm II Patients receive fludarabine as in arm I on days 1 3 and 5 In both arms patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and vaccination comprising gp100209-217210M peptide Montanide ISA-51 and keyhole limpet hemocyanin subcutaneously on days 8 22 36 50 and 64 Patients with stable or responding disease continue to receive vaccination on day 78 and then every 28-31 days for up to 1 year
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this study within 2 years
Primary
Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide gp100209-217210M Montanide ISA-51 and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma
Determine the induction of antigen-specific T-cell responses in patients treated with this regimen
Determine the kinetics and duration of immune response in patients treated with this regimen
Compare the immunologic effects of this regimen in these patients with historical results
Secondary
Compare 2 different dosing schedules of fludarabine in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine in these patients
OUTLINE This is a pilot randomized study Patients are randomized to 1 of 2 treatment arms
Within 2 weeks before the start of fludarabine all patients undergo leukapheresis over 4-6 hours for the collection of peripheral blood mononuclear cells PBMCs
Arm I Patients receive fludarabine IV over 30 minutes on days 1-5
Arm II Patients receive fludarabine as in arm I on days 1 3 and 5 In both arms patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and vaccination comprising gp100209-217210M peptide Montanide ISA-51 and keyhole limpet hemocyanin subcutaneously on days 8 22 36 50 and 64 Patients with stable or responding disease continue to receive vaccination on day 78 and then every 28-31 days for up to 1 year
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 20 patients 10 per treatment arm will be accrued for this study within 2 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 |
|---|---|---|---|
| PPMC-IRB-02-99 | None | None | None |
| NCI-6361 | None | None | None |