Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002482
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer
Sponsor:
St Vincent Medical Center - Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I-II TRIAL OF MUROMONAB OKT-3 WITH LOW-DOSE CYCLOPHOSPHAMIDE
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 III trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer
PURPOSE Phase III trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer
Detailed Description:
OBJECTIVES I Evaluate the clinical feasibility and toxicity of monoclonal antibody OKT3 given with low-dose cyclophosphamide in patients with advanced malignancies II Perform serial immune monitoring on patients treated with this regimen III Identify any clinical responses produced by this regimen
OUTLINE Biological Response Modifier Therapy with Suppressor Cell Inhibition Anti-CD3 Murine Monoclonal Antibody OKT3 MOAB OKT3 with Cyclophosphamide CTX NSC-26271
PROJECTED ACCRUAL At least 9 evaluable patients per diagnostic category will be required initially if any response is seen during the dose-finding portion of the study a total of 24 patients with that diagnosis will be entered
OUTLINE Biological Response Modifier Therapy with Suppressor Cell Inhibition Anti-CD3 Murine Monoclonal Antibody OKT3 MOAB OKT3 with Cyclophosphamide CTX NSC-26271
PROJECTED ACCRUAL At least 9 evaluable patients per diagnostic category will be required initially if any response is seen during the dose-finding portion of the study a total of 24 patients with that diagnosis will be entered
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 |
|---|---|---|---|
| NCI-V90-0206 | None | None | None |
| SVMC-ONC-121 | None | None | None |