Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032188
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2002-03-08
Brief Title:
Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study Of Interluekin-2 In Combination With Three Different Doses Of Bryostatin In Patients With Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill more tumor cells Randomized phase II trial to study the effectiveness of combining interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with advanced renal cell carcinoma treated with interleukin-2 IL-2 and bryostatin 1
II Compare the toxicity of 3 different doses of bryostatin 1 given in combination with a fixed dose of IL-2 in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of three dose levels of bryostatin 1
ARM I Patients receive interleukin-2 IL-2 subcutaneously on days 1-4 8-11 and 15-18 For the second and subsequent courses of IL-2 patients also receive lowest dose bryostatin 1 IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive IL-2 as in arm I and middle dose bryostatin 1 IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients receive IL-2 as in arm I and highest dose bryostatin 1 IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Patients with stable or responding disease may receive 3 additional courses of therapy An additional cohort of patients receives treatment as above at a higher dose to evaluate toxicity
Patients are followed for 1 year
PROJECTED ACCRUAL A total of 24-65 patients 8-16 per bryostatin 1 dose level will be accrued for this study within 14-27 months
I Determine the objective response rate in patients with advanced renal cell carcinoma treated with interleukin-2 IL-2 and bryostatin 1
II Compare the toxicity of 3 different doses of bryostatin 1 given in combination with a fixed dose of IL-2 in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of three dose levels of bryostatin 1
ARM I Patients receive interleukin-2 IL-2 subcutaneously on days 1-4 8-11 and 15-18 For the second and subsequent courses of IL-2 patients also receive lowest dose bryostatin 1 IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive IL-2 as in arm I and middle dose bryostatin 1 IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients receive IL-2 as in arm I and highest dose bryostatin 1 IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity
Patients with stable or responding disease may receive 3 additional courses of therapy An additional cohort of patients receives treatment as above at a higher dose to evaluate toxicity
Patients are followed for 1 year
PROJECTED ACCRUAL A total of 24-65 patients 8-16 per bryostatin 1 dose level will be accrued for this study within 14-27 months
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 |
|---|---|---|---|
| CDR0000069267 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17102 |
| 11367 | None | None | None |
| N01CM17102 | NIH | None | None |