A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Charles L. Wiseman, MD, FACP
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
CDR0000077247
NCT ID:
NCT00002482
Start Date:
June 1991
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| St. Vincent Medical Center - Los Angeles | Los Angeles, California 90057 |
