Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003665
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of a Dendritic Cell Vaccine for Melanoma
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma Vaccines may make the body build an immune response to kill tumor cells
Detailed Description:
OBJECTIVES
I Determine the dose-limiting toxicities maximum tolerated dose recommended phase II dose and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine
II Determine the overall complete and partial response rate duration of response and optimal route of administration in this patient population
OUTLINE This is a dose escalation study Patients are randomized to one of three treatment arms
All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell DC vaccine In each arm cohorts of up to 5 patients receive escalating doses of vaccine The maximum tolerated dose MTD is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity Randomization ceases if the MTD has been reached in 2 arms although accrual may continue Treatment repeats every 2 weeks for a total of 4 doses
Arm I Patients receive 3 different doses of peptide pulsed DC vaccine IV each divided into 3 different peptide pulsed pools administered over 30 minutes
Arm II Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneouslyintradermally to sites with no evidence of disease At the lowest dose patients receive 3 different peptide pulsed pools each administered at a separate site At the higher doses patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites
Arm III Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II At the lower dose patients receive 3 different peptide pulsed pools each administered into a different node At the higher dose patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites
Patients are followed at 2 weeks and then monthly for 3 months
I Determine the dose-limiting toxicities maximum tolerated dose recommended phase II dose and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine
II Determine the overall complete and partial response rate duration of response and optimal route of administration in this patient population
OUTLINE This is a dose escalation study Patients are randomized to one of three treatment arms
All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell DC vaccine In each arm cohorts of up to 5 patients receive escalating doses of vaccine The maximum tolerated dose MTD is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity Randomization ceases if the MTD has been reached in 2 arms although accrual may continue Treatment repeats every 2 weeks for a total of 4 doses
Arm I Patients receive 3 different doses of peptide pulsed DC vaccine IV each divided into 3 different peptide pulsed pools administered over 30 minutes
Arm II Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneouslyintradermally to sites with no evidence of disease At the lowest dose patients receive 3 different peptide pulsed pools each administered at a separate site At the higher doses patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites
Arm III Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II At the lower dose patients receive 3 different peptide pulsed pools each administered into a different node At the higher dose patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites
Patients are followed at 2 weeks and then monthly for 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 |
|---|---|---|---|
| CDR0000066759 | REGISTRY | PDQ Physician Data Query | None |
| UPCC-4697 | None | None | None |
| NCI-T98-0033 | None | None | None |