Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030342
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-02-14
Brief Title:
Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
Sponsor:
St Lukes Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Of Interleukin-12-Primed Activated T Cells In Combination With 5FU GM-CSF And Interferon Alfa-2b In Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2008-10
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining biological therapy with chemotherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of biological therapy combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer
PURPOSE Phase III trial to study the effectiveness of biological therapy combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer
Detailed Description:
OBJECTIVES
Determine the safety of a repeat course of interleukin-12-primed activated T cells 12ATC in combination with fluorouracil sargramostim GM-CSF and interferon alfa-2b in patients with metastatic renal cell or colorectal carcinoma
Determine the clinical responses of patients treated with this regimen
Determine the efficacy of 12ATC in these patients
Determine whether there are changes in immunologic parameters related to 12ATC as measured by lymphocyte phenotype and cytokine secretion in these patients
Determine the correlation between clinical responses in patients treated with this regimen and in vitro immune functions of lymphocytes
OUTLINE Patients are stratified according to disease type renal cell carcinoma vs colorectal carcinoma
Patients receive sargramostim GM-CSF subcutaneously SC daily on days 1-5 and then undergo collection of autologous peripheral blood mononuclear cells PBMC on days 6 and 7 of week 1 The PBMC are treated ex vivo to form interleukin-12-primed activated T cells 12ATC
Patients receive fluorouracil IV over 24 hours on day 6 of week 2 and interferon alfa-2b SC and GM-CSF SC 3 times weekly on weeks 3-5 Patients receive 12ATC IV over 15-30 minutes twice weekly and interferon alfa-2b SC at least 24 hours after 12ATC infusion once weekly on weeks 6-8 Patients with complete or partial response or stable disease at 3 weeks after the last 12ATC infusion may receive an additional 8-week course as above
Patients are followed every 2-3 months for 1 year and then every 6 months for 2 years or at any time when the physical examination or symptoms are suspicious for tumor progression
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study within 2-3 years
Determine the safety of a repeat course of interleukin-12-primed activated T cells 12ATC in combination with fluorouracil sargramostim GM-CSF and interferon alfa-2b in patients with metastatic renal cell or colorectal carcinoma
Determine the clinical responses of patients treated with this regimen
Determine the efficacy of 12ATC in these patients
Determine whether there are changes in immunologic parameters related to 12ATC as measured by lymphocyte phenotype and cytokine secretion in these patients
Determine the correlation between clinical responses in patients treated with this regimen and in vitro immune functions of lymphocytes
OUTLINE Patients are stratified according to disease type renal cell carcinoma vs colorectal carcinoma
Patients receive sargramostim GM-CSF subcutaneously SC daily on days 1-5 and then undergo collection of autologous peripheral blood mononuclear cells PBMC on days 6 and 7 of week 1 The PBMC are treated ex vivo to form interleukin-12-primed activated T cells 12ATC
Patients receive fluorouracil IV over 24 hours on day 6 of week 2 and interferon alfa-2b SC and GM-CSF SC 3 times weekly on weeks 3-5 Patients receive 12ATC IV over 15-30 minutes twice weekly and interferon alfa-2b SC at least 24 hours after 12ATC infusion once weekly on weeks 6-8 Patients with complete or partial response or stable disease at 3 weeks after the last 12ATC infusion may receive an additional 8-week course as above
Patients are followed every 2-3 months for 1 year and then every 6 months for 2 years or at any time when the physical examination or symptoms are suspicious for tumor progression
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study within 2-3 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 |
|---|---|---|---|
| NCI-V01-1686 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069153 | REGISTRY | None | None |
| STLMC-L-01108 | None | None | None |