Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085306
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2004-06-10
Brief Title:
Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
Status:
COMPLETED
Status Verified Date:
2015-10
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 Interferon beta may interfere with the growth of tumor cells
PURPOSE This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous skin melanoma or ocular eye melanoma
PURPOSE This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous skin melanoma or ocular eye melanoma
Detailed Description:
OBJECTIVES
Determine the objective clinical response rate in patients with metastatic cutaneous or ocular melanoma treated with interferon beta
Determine the frequency and degree of apoptosis induction in patients treated with this drug
Determine the safety and tolerability of this drug in these patients
OUTLINE This is an open-label study Patients are stratified according to type of melanoma ocular vs cutaneous
Patients receive interferon beta subcutaneously once daily in the absence of disease progression or unacceptable toxicity
Patients are followed within 3 days after completion of study treatment and then for survival
PROJECTED ACCRUAL A total of 28-56 patients 14-28 per stratum will be accrued for this study
Determine the objective clinical response rate in patients with metastatic cutaneous or ocular melanoma treated with interferon beta
Determine the frequency and degree of apoptosis induction in patients treated with this drug
Determine the safety and tolerability of this drug in these patients
OUTLINE This is an open-label study Patients are stratified according to type of melanoma ocular vs cutaneous
Patients receive interferon beta subcutaneously once daily in the absence of disease progression or unacceptable toxicity
Patients are followed within 3 days after completion of study treatment and then for survival
PROJECTED ACCRUAL A total of 28-56 patients 14-28 per stratum will be accrued for this study
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 |
|---|---|---|---|
| CASE1604 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CCF-4049 | OTHER | None | None |