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

February 23, 2010 updated by: Envita Medical Center, Inc.

A Phase I Open Label, Single Site, Safety and Efficacy Study of the Effects of Autologous Natural Killer and Natural Killer T Cell Immunotherapy on Malignant Disease

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Biological: Autologous Natural Killer / Natural Killer T Cell Immunotherapy

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Scottsdale, Arizona, United States, 85260
    - Envita Medical Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female not less than 18 years of age or over 80 years of age.
Life expectancy of ≥ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
Subjects must present with one of the following disease pathologies: Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer or Prostate Cancer
The pathology must be an assessable disease (measurable by CT scan or MRI) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
Negative for hepatitis B, hepatitis C, HIV, and CMV.
Subjects must present with leukocyte counts above 3,000/μL and platelet counts above 100,000/ μL.
Subjects must present with minimum hemoglobin levels of 10.
If female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses >12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (IUD) or sexual abstinence, or has a vasectomized partner.
If female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit.
Able to comprehend and sign an informed consent document and comply with the requirements of the study.

Exclusion Criteria:

No measurable malignant disease by CT scan or tumor markers.
Life expectancy of ≤ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
Age of less than 18 years or over 80 years of age.
Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV.
Prior or current history of autoimmune disease.
Pregnant or lactating women.
Leukocyte count < 3,000 /μL prior to leukapheresis.
Platelet count < 100,000/μL prior to leukapheresis.
Hemoglobin levels below 10.
PTT (prothrombin time) of < 12 seconds or > than 15 seconds.
aPTT (activated partial thromboplastin time) of < 25 seconds or > than 39 seconds.
Failure or refusal to sign informed consent for the study.
Culture fails to meet specifications for study.
Subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Is there any measurable effect upon the underlying cancer as assessed by an increase or decrease in the tumor as measured from baseline using established criteria? Time Frame: 5 -15 Weeks	5 -15 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Are the dosages administered during the study safe, as measured by the number of unexpected and serious adverse events associated with the study drug, as defined by FDA regulations and as measured by established criteria? Time Frame: 5 - 15 weeks	5 - 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Envita Medical Center, Inc.

Investigators

Principal Investigator: David Korn, D.O., M.D., Envita Medical Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria