Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005038
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-04-06
Brief Title:
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
Sponsor:
The Christie NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy With Subcutaneous Interleukin-2 and Maxamine in Patients With Metastatic Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2001-06
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 Interleukin-2 may stimulate a persons white blood cells to kill kidney cancer cells Histamine dihydrochloride may prolong survival and improve quality of life in patients with metastatic kidney cancer
PURPOSE Randomized phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer
PURPOSE Randomized phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the clinical efficacy and safety of subcutaneous SC histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal cell carcinoma in terms of survival at 1 year objective tumor response rate duration of response and median survival
OUTLINE This is a randomized open label study Patients are randomized to receive interleukin-2 IL-2 with or without histamine dihydrochloride
Arm I Patients receive IL-2 subcutaneously SC once daily and histamine dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest
Arm II Patients receive IL-2 as in arm I Treatment continues for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study
Determine the clinical efficacy and safety of subcutaneous SC histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal cell carcinoma in terms of survival at 1 year objective tumor response rate duration of response and median survival
OUTLINE This is a randomized open label study Patients are randomized to receive interleukin-2 IL-2 with or without histamine dihydrochloride
Arm I Patients receive IL-2 subcutaneously SC once daily and histamine dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest
Arm II Patients receive IL-2 as in arm I Treatment continues for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 60 patients 30 per arm 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 |
|---|---|---|---|
| MAXIM-MP-502 | None | None | None |
| CHNT-IL2-MAXAMINE | None | None | None |
| EU-99048 | None | None | None |