Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019396
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
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:
RATIONALE The drug flt3L may stimulate a persons immune system and help to kill tumor cells Vaccines made from melanoma cells may make the body build an immune response to and kill their tumor cells
PURPOSE Phase II trial to study the effectiveness of flt3L with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer
PURPOSE Phase II trial to study the effectiveness of flt3L with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer
Detailed Description:
OBJECTIVES I Evaluate the immunologic and biologic activity of flt3 ligand Flt3L alone in patients with metastatic renal cell cancer or HLA-A21 negative melanoma
II Evaluate the immunologic and biologic activity of Flt3L alone or in combination with melanoma peptide immunization MART-1 gp100209-217 gp100280-288 and tyrosinase in patients with metastatic HLA-A21 positive melanoma
PROTOCOL OUTLINE Patients are assigned to 1 of 3 treatment groups
Group 1 renal cell cancer Patients receive Flt3 ligand Flt3L subcutaneously SQ alone on days 1-14
Group 2 HLA-A21 negative melanoma Patients receive Flt3L SQ alone on days 1-14
Group 3 HLA-A21 positive melanoma Patients may receive either Flt3L SQ alone on days 1-14 or in combination with melanoma peptide immunization Patients may receive melanoma peptide immunization comprised of MART-1 immunodominant peptide gp100209-217 gp100280-288 and tyrosinase peptide emulsified in Montanide ISA-51 SQ on day 12 of Flt3L administration
Treatment repeats every 4 weeks for 2 courses Patients with no response or minor response may receive 2 additional courses Patients with disease progression after 1 course are removed from study
PROJECTED ACCRUAL
Approximately 54-96 patients 18-32 per treatment group will be accrued for this study within 16 months
II Evaluate the immunologic and biologic activity of Flt3L alone or in combination with melanoma peptide immunization MART-1 gp100209-217 gp100280-288 and tyrosinase in patients with metastatic HLA-A21 positive melanoma
PROTOCOL OUTLINE Patients are assigned to 1 of 3 treatment groups
Group 1 renal cell cancer Patients receive Flt3 ligand Flt3L subcutaneously SQ alone on days 1-14
Group 2 HLA-A21 negative melanoma Patients receive Flt3L SQ alone on days 1-14
Group 3 HLA-A21 positive melanoma Patients may receive either Flt3L SQ alone on days 1-14 or in combination with melanoma peptide immunization Patients may receive melanoma peptide immunization comprised of MART-1 immunodominant peptide gp100209-217 gp100280-288 and tyrosinase peptide emulsified in Montanide ISA-51 SQ on day 12 of Flt3L administration
Treatment repeats every 4 weeks for 2 courses Patients with no response or minor response may receive 2 additional courses Patients with disease progression after 1 course are removed from study
PROJECTED ACCRUAL
Approximately 54-96 patients 18-32 per treatment group will be accrued for this study within 16 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-T97-0092 | None | None | None |
| NCI-98-C-0040 | None | None | None |