Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016055
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-05-06
Brief Title:
Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
Sponsor:
St Lukes Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma Phase I
Status:
UNKNOWN
Status Verified Date:
2006-11
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 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 I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the safety of interleukin-12-primed activated T cells 12ATC and temozolomide in patients with metastatic melanoma
Determine the maximum tolerated dose of 12ATC in this patient population
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 undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells PBMC are obtained The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3 interleukin-2 and interleukin-12 to form 12ATC
Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22 25 29 32 36 39 50 53 57 60 64 and 67 in the absence of disease progression or unacceptable toxicity
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 at least 2 patients experience dose-limiting toxicity
Patients are followed weekly for 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
Determine the safety of interleukin-12-primed activated T cells 12ATC and temozolomide in patients with metastatic melanoma
Determine the maximum tolerated dose of 12ATC in this patient population
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 undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells PBMC are obtained The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3 interleukin-2 and interleukin-12 to form 12ATC
Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22 25 29 32 36 39 50 53 57 60 64 and 67 in the absence of disease progression or unacceptable toxicity
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 at least 2 patients experience dose-limiting toxicity
Patients are followed weekly for 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:
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-V01-1657 | None | None | None |
| STLMC-IMM-0002 | None | None | None |