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Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer

NCT ID: NCT00002482

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1991-06-30

Brief Summary

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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

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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

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Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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unspecified adult solid tumor, protocol specific

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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antibody therapy

Intervention Type BIOLOGICAL

biological therapy

Intervention Type BIOLOGICAL

muromonab-CD3

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Vincent Medical Center - Los Angeles

OTHER

Sponsor Role lead

Principal Investigators

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Charles L. Wiseman, MD, FACP

Role: STUDY_CHAIR

Locations

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St. Vincent Medical Center - Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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SVMC-ONC-121

Identifier Type: -

Identifier Source: secondary_id

NCI-V90-0206

Identifier Type: -

Identifier Source: secondary_id

CDR0000077247

Identifier Type: -

Identifier Source: org_study_id