Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217542
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2005-09-20
Brief Title:
Azacitidine and Recombinant Interferon Alfa-2b in Treating Patients With Stage III or Stage IV Melanoma or Stage IV Kidney Cancer That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of 5-azacitidine in Combination With Interferon-Alfa 2B in Unresectable or Metastatic Melanoma and Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-05
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:
This phase I trial is studying the side effects and best dose of recombinant interferon alfa-2b when given together with azacitidine in treating patients with stage III or stage IV melanoma or stage IV kidney cancer that cannot be removed by surgery Drugs used in chemotherapy such as azacitidine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Recombinant interferon alfa-2b may interfere with the growth of tumor cells Giving azacitidine together with recombinant interferon alfa-2b may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the adverse event profile and maximum tolerated dose of interferon alfa-2b when combined with azacitidine in patients with unresectable stage III or IV melanoma or unresectable stage IV renal cell carcinoma
II Determine the feasibility of this regimen for future phase II trials
OUTLINE This is a dose-escalation multicenter study
Patients receive azacitidine subcutaneously SC once daily on days 1-4 and 15-17 and recombinant interferon alfa-2b SC on days 8 10 12 15 17 19 22 24 and 26 during course 1 Beginning in course 2 and for all subsequent courses patients receive azacitidine SC once daily on days 1-3 and 15-17 and interferon alfa-2b SC on days 1 3 5 8 10 12 15 17 19 22 24 and 26 Treatment repeats every 28 days for up to 12 total courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interferon alfa-2b 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 After completion of study treatment patients are followed every 2-4 months
I Determine the adverse event profile and maximum tolerated dose of interferon alfa-2b when combined with azacitidine in patients with unresectable stage III or IV melanoma or unresectable stage IV renal cell carcinoma
II Determine the feasibility of this regimen for future phase II trials
OUTLINE This is a dose-escalation multicenter study
Patients receive azacitidine subcutaneously SC once daily on days 1-4 and 15-17 and recombinant interferon alfa-2b SC on days 8 10 12 15 17 19 22 24 and 26 during course 1 Beginning in course 2 and for all subsequent courses patients receive azacitidine SC once daily on days 1-3 and 15-17 and interferon alfa-2b SC on days 1 3 5 8 10 12 15 17 19 22 24 and 26 Treatment repeats every 28 days for up to 12 total courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of interferon alfa-2b 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 After completion of study treatment patients are followed every 2-4 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 |
|---|---|---|---|
| CDR0000441640 | None | None | None |
| YALE HIC27409 | None | None | None |
| YALE-HIC-27409 | None | None | None |
| NCI-7317 | None | None | None |