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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002482

Enrollment

Unknown

Registered

2004-06-28

Start date

1991-06-30

Completion date

Unknown

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

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/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.

Interventions

BIOLOGICALantibody therapy

BIOLOGICALbiological therapy

BIOLOGICALmuromonab-CD3

DRUGcyclophosphamide

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: Metastatic cancer considered incurable by standard therapy and for which no higher priority protocol is available Locally progressive primary brain tumors (e.g., astrocytoma, glioma) are also eligible Brain metastases allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-4 (poor performance status brain tumor patients specifically eligible) Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No history of adult asthma No emphysema No pulmonary insufficiency No pulmonary edema Other: No AIDS or positive HIV serology No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026