Trials / Unknown
UnknownNCT00002482
Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer
A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- St. Vincent Medical Center - Los Angeles · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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/II 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | antibody therapy | |
| BIOLOGICAL | biological therapy | |
| BIOLOGICAL | muromonab-CD3 | |
| DRUG | cyclophosphamide |
Timeline
- Start date
- 1991-06-01
- First posted
- 2004-06-28
- Last updated
- 2013-11-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002482. Inclusion in this directory is not an endorsement.