Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002746
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A PHASE I TRIAL OF SUBCUTANEOUS OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME MDS
Status:
COMPLETED
Status Verified Date:
2019-02
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 in treating patients with myelodysplastic syndrome
PURPOSE Phase I trial to study the effectiveness of interleukin-2 in treating patients with myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the safety tolerance and maximum tolerated dose of subcutaneous interleukin-2 aldesleukin IL-2 in patients with myelodysplastic syndrome MDS
Evaluate the hematologic effects of subcutaneous IL-2 in MDS
OUTLINE IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks After each cycle the patient will be evaluated for response The patient could continue IL-2 therapy for up to 12 cycles There are 4 dose levels of IL-2 At each dose level 3 patients will be accrued sequentially
Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs After the patient returns to baseline pretherapy values or grade I toxicity the subject will resume IL-2 at 50 of the initial dose If the patient again goes into grade III toxicity or is in need of hospitalization IL-2 will be discontinued
PROJECTED ACCRUAL Between 12-24 patients will be accrued
Determine the safety tolerance and maximum tolerated dose of subcutaneous interleukin-2 aldesleukin IL-2 in patients with myelodysplastic syndrome MDS
Evaluate the hematologic effects of subcutaneous IL-2 in MDS
OUTLINE IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks After each cycle the patient will be evaluated for response The patient could continue IL-2 therapy for up to 12 cycles There are 4 dose levels of IL-2 At each dose level 3 patients will be accrued sequentially
Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs After the patient returns to baseline pretherapy values or grade I toxicity the subject will resume IL-2 at 50 of the initial dose If the patient again goes into grade III toxicity or is in need of hospitalization IL-2 will be discontinued
PROJECTED ACCRUAL Between 12-24 patients will be accrued
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-V96-0848 | None | None | None |
| UW-26-245-B | None | None | None |