Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020540
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Brief Title:
Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L
Status:
COMPLETED
Status Verified Date:
2002-04
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 such as flt3L and CD40-ligand use different ways to stimulate the immune system and stop cancer cells from growing Biological therapy may be an effective treatment for metastatic melanoma and metastatic kidney cancer
PURPOSE Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in treating patients who have metastatic melanoma or metastatic kidney cancer
PURPOSE Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in treating patients who have metastatic melanoma or metastatic kidney cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of CD40-ligand when combined with fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer
OUTLINE This is a dose-escalation study of CD40-ligand Patients receive fixed-dose flt3 ligand subcutaneously SC daily on days 1-14 and CD40-ligand SC daily on days 12-16 Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3 to 6 patients receive escalating doses of CD40-ligand until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2 IL-2 standard therapy
PROJECTED ACCRUAL A total of 5 patients were accrued for this study
OUTLINE This is a dose-escalation study of CD40-ligand Patients receive fixed-dose flt3 ligand subcutaneously SC daily on days 1-14 and CD40-ligand SC daily on days 12-16 Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3 to 6 patients receive escalating doses of CD40-ligand until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2 IL-2 standard therapy
PROJECTED ACCRUAL A total of 5 patients were 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-1035 | None | None | None |
| NCI-01-C-0121 | None | None | None |