Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00095108
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2004-10-29
Brief Title:
Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
Sponsor:
ZymoGenetics
Organization:
ZymoGenetics
Study Overview
Official Title:
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 rIL-21 in Subjects With Metastatic Melanoma or Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-03
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 study is being done to see if an experimental drug called recombinant interleukin-21 rIL-21 when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers
Detailed Description:
This is a phase 1 safety study Everyone enrolled and eligible will be given rIL-21 The study has 2 parts Part A will determine how high a dose of rIl-21 can be safely given to patients with these types of cancers Part B will determine if the drug is of any benefit to patients with these types of cancers Part A may have up to 7 different dose groups Beginning with the lowest dose 3 patients will be treated and will be watched for side effects If the side effects are not severe the next group of 3 patients will recieve a higher dose This cycle is repeated until the highest tolerated dose group is found
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