Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016042
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-05-06
Brief Title:
Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
Sponsor:
St Lukes Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma Phase I
Status:
UNKNOWN
Status Verified Date:
2001-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop cancer cells from dividing so they stop growing or die Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining chemotherapy with biological therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of fluorouracil combined with biological therapy in treating patients who have metastatic kidney or colorectal cancer
PURPOSE Phase I trial to study the effectiveness of fluorouracil combined with biological therapy in treating patients who have metastatic kidney or colorectal cancer
Detailed Description:
OBJECTIVES I Determine the safety of fluorouracil and interleukin-12-primed activated T cells 12ATC with sargramostim GM-CSF and interferon alfa in patients with metastatic renal cell cancer or colorectal cancer II Determine the maximum tolerated dose of 12ATC in this patient population III Determine the clinical response of patients treated with this regimen
OUTLINE This is a dose-escalation study of interleukin-12-primed activated T cells 12ATC Patients receive sargramostim GM-CSF subcutaneously SC on days 1-5 and undergo leukopheresis on day 6 to obtain peripheral blood mononuclear cells PBMC Patients treated at dose level 3 also undergo leukopheresis on day 7 The PBMC are treated with monoclonal antibody anti-CD3 interleukin-12 and interleukin-2 to form 12ATC Patients receive chemoimmunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and GM-CSF and interferon alfa SC on days 17 19 21 24 26 and 28 Patients receive 12ATC IV over 15-30 minutes on days 31 34 38 41 45 and 48 and interferon alfa SC on days 35 42 and 49 Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed at 2 weeks every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 9-18 patients will be accrued for this study
OUTLINE This is a dose-escalation study of interleukin-12-primed activated T cells 12ATC Patients receive sargramostim GM-CSF subcutaneously SC on days 1-5 and undergo leukopheresis on day 6 to obtain peripheral blood mononuclear cells PBMC Patients treated at dose level 3 also undergo leukopheresis on day 7 The PBMC are treated with monoclonal antibody anti-CD3 interleukin-12 and interleukin-2 to form 12ATC Patients receive chemoimmunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and GM-CSF and interferon alfa SC on days 17 19 21 24 26 and 28 Patients receive 12ATC IV over 15-30 minutes on days 31 34 38 41 45 and 48 and interferon alfa SC on days 35 42 and 49 Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity Patients are followed at 2 weeks every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 9-18 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 |
|---|---|---|---|
| NCI-V01-1656 | None | None | None |
| STLMC-IMM-0001 | None | None | None |