Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412321
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2006-12-15
Brief Title:
A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkins Lymphoma Multiple Myeloma or Castlemans Disease
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 CNTO 328 in Subjects With B-Cell Non-Hodgkins Lymphoma Multiple Myeloma or Castlemans Disease
Status:
COMPLETED
Status Verified Date:
2014-06
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:
The purpose of this study is to evaluate of the study of different CNTO 328 doses and schedules and to see if CNTO 328 has any effect on Non-hodgkins Lymphoma Multiple Myeloma or Castlemans disease
Detailed Description:
This research study will use a type of drug called anti-IL-6 antibody also known as CNTO 328 An antibody is a substance in the body that fights infection CNTO 328 is an investigational drug that has been shown to slow down tumor growth or shrink tumors when tested in animals In a previous clinical trial in patients with multiple myeloma blood cancer CNTO 328 appeared to be a potent inhibitor of IL-6 One study has been completed for kidney cancer There are studies ongoing in humans with multiple myeloma and prostate cancer to see if CNTO 328 is safe and to see what effects it has on these types of cancer This is an open-label nonrandomized dose-finding phase 1 study with CNTO 328 in patients with B- cell non-Hodgkins Lymphoma Multiple Myeloma or Castlemans disease The purpose of this study is to evaluate different doses and schedules of CNTO 328 to see which doseschedule is safe CNTO 328 will be given through a small tube that goes directly into your vein called an intravenous IV infusion Depending on when the patient enters the study the patient will be assigned to receive one course of CNTO 328 in one of the following groups Group 1 3 mgkg 2 hr IV infusion every 2 weeks for 4 doses Group 2 6 mgkg 2 hr IV infusion every 2 weeks for 4 doses Group 3 12 mgkg 2 hr IV infusion every 3 weeks for 3 doses Group 4 6 mgkg 2 hr IV infusion every week for 7 doses Group 5 12 mgkg 2 hr IV infusion every 2 weeks for 4 doses Group 6 12 mgkg 1 hr IV infusion every 3 weeks for 3 doses Group 7a 9 mgkg 1 hr IV infusion every 3 weeks Group 7b 12 mgkg 1hr IV infusion every 3 weeks for Castlemans patients only In Groups 1-5 the overall amount of study drug that will be given increases with each higher group Group 1 will be filled before Group 2 starts and Group 2 will be filled before Group 3 starts etc In this way CNTO 328 can be tested more safely Both the patient and the study doctor will know to which group the patient is assigned Patients will remain in the group that they are assigned to for the entire time of participation in the study Up to 70 patients may take part in this study Patients in Groups 1-6 will be in the study for up to 34 weeks prior to Post Study Follow-Up Screening up to 4 weeks before the first dose schedule of CNTO 328 Treatment up to 6 weeks of treatment with CNTO 328 Extended Dosing Patients assigned to Groups 1-6 and their cancer or disease has become stable or better while receiving CNTO 328 may be able to receive additional courses of study drug Patients in Group 7 will be in the study until their disease gets worse they can no longer tolerate CNTO 328 the study doctor feels it is in their best interest to stop CNTO 328 or they longer wish to participate in the study Long Term Follow-Up Patients will be contacted by telephone every six months after the last infusion of study drug to assess the patients disease status and survival Dose 6-12 mgkg and frequency weekly or 2 or 3 week intervals of dosing depends upon Group assignment CNTO 328 will be given through a small tube that goes directly into your vein called an intravenous IV infusion The infusion will take about 2 hours to complete for groups 1-5 and 1 hour for Groups 6 and 7 In Groups 1-6 CNTO 328 will be given once every 1 2 or 3 weeks from days 1 to 43 depending on treatment assignment In Group 7a and Group 7b CNTO 328 will be given on day 1 of each 21 day cycle
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 |
|---|---|---|---|
| C0328T03 | OTHER | Centocor | None |