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A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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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 AngelesLos Angeles, California  90057