Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer

NCT00909558 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-02-24

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.

Conditions

Interventions

BIOLOGICAL

Autologous Natural Killer / Natural Killer T Cell Immunotherapy

The study drug is derived from ex vivo expansion of each subject's own white blood cells and is therefore autologous. The current study proposes a 3-course treatment of doses administered at one week intervals with monitoring at each administration plus 2 weeks after the last dose. The total study time (apheresis through last follow-up) is estimated at 15 weeks.

Sponsors & Collaborators

  • Envita Medical Center, Inc.

    lead INDUSTRY

Principal Investigators

  • David Korn, D.O., M.D. · Envita Medical Centers

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909558 on ClinicalTrials.gov