Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039234
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-06-06
Brief Title:
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
Sponsor:
Maxim Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Multi-Center Controlled Trial With Stratified Randomization Comparing The Efficacy Of Interleukin-2 IL-2 Plus Histamine Dihydrochloride HDC Versus IL-2 Alone To Increase The Duration Of Survival In Patients With AJCC Stage IV Malignant Melanoma With Hepatic Metastasis
Status:
UNKNOWN
Status Verified Date:
2003-12
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 tumor cells Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver
PURPOSE Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver
PURPOSE Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver
Detailed Description:
OBJECTIVES
Compare the duration of survival in patients with stage IV melanoma with hepatic metastasis treated with interleukin-2 with or without histamine dihydrochloride
Compare the progression-free survival response rate response rate of hepatic tumors and lack of disease progression in patients treated with these regimens
Determine the safety of these regimens in terms of frequency severity and causal relationship of adverse events in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center location North America vs Europe lactate dehydrogenase less than ULN vs ULN or greater and metastatic sites liver only vs liver and other sites Patients are randomized to one of two treatment arms
Arm I Patients receive interleukin-2 IL-2 subcutaneously SC twice daily on days 1 and 2 of weeks 1 and 3 and days 1-5 of weeks 2 and 4 Patients also receive histamine dihydrochloride SC over 10-30 minutes on days 1-5 of weeks 1-4
Arm II Patients receive IL-2 as in arm I In both arms treatment repeats every 6 weeks for at least 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 224 patients 112 per treatment arm will be accrued for this study
Compare the duration of survival in patients with stage IV melanoma with hepatic metastasis treated with interleukin-2 with or without histamine dihydrochloride
Compare the progression-free survival response rate response rate of hepatic tumors and lack of disease progression in patients treated with these regimens
Determine the safety of these regimens in terms of frequency severity and causal relationship of adverse events in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center location North America vs Europe lactate dehydrogenase less than ULN vs ULN or greater and metastatic sites liver only vs liver and other sites Patients are randomized to one of two treatment arms
Arm I Patients receive interleukin-2 IL-2 subcutaneously SC twice daily on days 1 and 2 of weeks 1 and 3 and days 1-5 of weeks 2 and 4 Patients also receive histamine dihydrochloride SC over 10-30 minutes on days 1-5 of weeks 1-4
Arm II Patients receive IL-2 as in arm I In both arms treatment repeats every 6 weeks for at least 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 224 patients 112 per treatment 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 |
|---|---|---|---|
| MSKCC-03057 | None | None | None |
| MAXIM-MP-8899-0104 | None | None | None |
| UCLA-0111056 | None | None | None |
| NCI-G02-2070 | None | None | None |