Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003993
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
1999-11-01
Brief Title:
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
Sponsor:
National Institute on Aging NIA
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2 Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 cancer cells from dividing so they stop growing or die Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining chemotherapy and interleukin-2 may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas
Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients
Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells
Assess any anti-tumor response in these patients treated with this regimen
OUTLINE This is a dose escalation study of interleukin-2
Patients receive bryostatin 1 IV over 24 hours on days 1 and 8 and interleukin-2 subcutaneously on days 1-5 and days 8-12 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interleukin-2 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
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study in less than 2 years
Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas
Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients
Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells
Assess any anti-tumor response in these patients treated with this regimen
OUTLINE This is a dose escalation study of interleukin-2
Patients receive bryostatin 1 IV over 24 hours on days 1 and 8 and interleukin-2 subcutaneously on days 1-5 and days 8-12 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interleukin-2 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
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study in less than 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 |
|---|---|---|---|
| LSUMC-9901 | None | None | None |
| NCI-T99-0015 | None | None | None |