Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003962
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
1999-11-01
Brief Title:
Interleukin-2 Following Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Dose Finding Study of Toxicity and Immunomodulatory Effects of Interleukin-2 Following Allogeneic Bone Marrow Transplantation in Patients at High Risk for Relapse
Status:
COMPLETED
Status Verified Date:
2014-05
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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse
PURPOSE Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of interleukin-2 following allogeneic T-cell depleted bone marrow transplant in patients with hematologic malignancies at high risk of relapse II Determine the optimal dose of interleukin-2 in this regimen which will result in maximal natural killer cell and lymphokine activated killer cell activity in vitro
OUTLINE This is a dose escalation study Patients receive CD34 stem cell augmented donor bone marrow on day 0 on another protocol Patients then receive interleukin-2 IL-2 subcutaneously on day 30 Treatment continues for 12 weeks in the absence of dose limiting toxicity Cohorts of 4 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose prior to that which causes at least grade 3 toxicity
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose escalation study Patients receive CD34 stem cell augmented donor bone marrow on day 0 on another protocol Patients then receive interleukin-2 IL-2 subcutaneously on day 30 Treatment continues for 12 weeks in the absence of dose limiting toxicity Cohorts of 4 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose prior to that which causes at least grade 3 toxicity
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| NCI-H99-0033 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA015396 |
| P01CA015396 | NIH | None | None |
| JHOC-98040902 | None | None | None |
| JHOC-J9825 | None | None | None |