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Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer

Sponsor
St. Vincent Medical Center - Los Angeles (Other)
Overall Status
Unknown status
CT.gov ID
NCT00002482
Collaborator
(none)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: antibody therapy
  • Biological: biological therapy
  • Biological: muromonab-CD3
  • Drug: cyclophosphamide
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE
Study Start Date :
Jun 1, 1991

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Vincent Medical Center - Los Angeles Los Angeles California United States 90057

    Sponsors and Collaborators

    • St. Vincent Medical Center - Los Angeles

    Investigators

    • Study Chair: Charles L. Wiseman, MD, FACP,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002482
    Other Study ID Numbers:
    • CDR0000077247
    • SVMC-ONC-121
    • NCI-V90-0206
    First Posted:
    Jun 28, 2004
    Last Update Posted:
    Nov 6, 2013
    Last Verified:
    Jul 1, 2007
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Cyclophosphamide
    Muromonab-CD3
    Antibodies

    Study Results

    No Results Posted as of Nov 6, 2013