Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005061
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-04-06
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase I Open Label Multiple Dose Safety and Pharmacokinetic Study of Intravenously Administered Humanized Anti-VEGF Monoclonal Antibody HuMV833 to Patients With Relapsed or Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-07
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the preliminary tolerability and safety of monoclonal antibody VEGF MOAB VEGF in patients with relapsed or refractory progressive solid tumors II Determine the optimum biologically active dose of MOAB VEGF for further evaluation based on exploratory methods III Determine the maximum tolerated dose of MOAB VEGF in these patients IV Determine a safe dose of MOAB VEGF for further clinical studies V Determine the dose limiting toxicity and pharmacokinetics of this regimen in these patients VI Determine the response rate in patients treated with this regimen
OUTLINE This is a dose escalation multicenter study Patients receive monoclonal antibody VEGF MOAB VEGF IV over 1 hour on days 1 15 22 and 29 Patients with partial response PR complete response CR or stable disease SD after completion of the fourth dose may receive weekly infusions for up to 6 months in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of MOAB VEGF until the maximum tolerated dose MTD and optimum biologically active dose OBAD are determined The MTD is defined as the dose at which 1 of 6 patients experiences dose limiting toxicity The OBAD is defined as the dose at which vascular endothelial growth factor is optimally inhibited Patients with PR CR or SD are evaluated every 6 weeks until disease progression or initiation of another treatment Patients who discontinue treatment prematurely due to toxicity are followed weekly until resolution of any associated toxicity Patients who discontinue treatment after the fourth dose of MOAB VEGF for any reason other than toxicity are followed every month for up to 6 months
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study Patients receive monoclonal antibody VEGF MOAB VEGF IV over 1 hour on days 1 15 22 and 29 Patients with partial response PR complete response CR or stable disease SD after completion of the fourth dose may receive weekly infusions for up to 6 months in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of MOAB VEGF until the maximum tolerated dose MTD and optimum biologically active dose OBAD are determined The MTD is defined as the dose at which 1 of 6 patients experiences dose limiting toxicity The OBAD is defined as the dose at which vascular endothelial growth factor is optimally inhibited Patients with PR CR or SD are evaluated every 6 weeks until disease progression or initiation of another treatment Patients who discontinue treatment prematurely due to toxicity are followed weekly until resolution of any associated toxicity Patients who discontinue treatment after the fourth dose of MOAB VEGF for any reason other than toxicity are followed every month for up to 6 months
PROJECTED ACCRUAL A maximum of 25 patients 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 |
|---|---|---|---|
| PDL-833-601 | None | None | None |
| EORTC-13992 | None | None | None |