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Status unknownNCT00002482Updated Nov 6, 2013

Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer

A Phase 1/2 interventional study of antibody therapy and biological therapy in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by St. Vincent Medical Center - Los Angeles. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by St. Vincent Medical Center - Los Angeles · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
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In context

Lead sponsor

St. Vincent Medical Center - Los Angeles is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment

Interventions

  • Biologicalantibody therapy
  • Biologicalbiological therapy
  • Biologicalmuromonab-CD3
  • Drugcyclophosphamide
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Study locations

1 site
  • St. Vincent Medical Center - Los Angeles
    Los Angeles, California 90057, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00002482
Lead sponsor
St. Vincent Medical Center - Los Angeles
First posted
Jun 28, 2004
Start date
Jun 1991
Last update
Nov 6, 2013

Study contacts

Charles L. Wiseman, MD, FACP
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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