Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006022
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2000-07-05
Brief Title:
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase IAIB Trial of Modulation of the Biological Response to Interleukin-2 IL-2 With Bryostatin 1 BRYO NSC 339555
Status:
COMPLETED
Status Verified Date:
2015-12
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Combining bryostatin 1 with interleukin-2 may kill more tumor cells
PURPOSE Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery
PURPOSE Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery
Detailed Description:
OBJECTIVES
Determine the dose of bryostatin 1 that when administered in conjunction with low-dose interleukin-2 maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma
Assess other intermediate markers of immune response in patients treated with this regimen
Determine tumor responses response durations progression-free intervals and survival of patients treated with this regimen
OUTLINE This is a randomized double-blind study Patients are randomized to one of three bryostatin 1 dose levels
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study within 2 years
Determine the dose of bryostatin 1 that when administered in conjunction with low-dose interleukin-2 maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma
Assess other intermediate markers of immune response in patients treated with this regimen
Determine tumor responses response durations progression-free intervals and survival of patients treated with this regimen
OUTLINE This is a randomized double-blind study Patients are randomized to one of three bryostatin 1 dose levels
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21 patients will be accrued for this study within 2 years
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-T99-0049 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |
| P30CA016059 | NIH | None | None |
| MCV-MCCCCHR-9910-2A | None | None | None |