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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909558
Recruitment Status : Suspended
First Posted : May 28, 2009
Last Update Posted : February 24, 2010
Information provided by:
Envita Medical Center, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Glioma Hepatocellular Cancer Squamous Cell Lung Cancer Pancreatic Cancer Colon Cancer Prostate Cancer Biological: Autologous Natural Killer / Natural Killer T Cell Immunotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2009
Estimated Primary Completion Date : June 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909558

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United States, Arizona
Envita Medical Centers
Scottsdale, Arizona, United States, 85260
Sponsors and Collaborators
Envita Medical Center, Inc.
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Principal Investigator: David Korn, D.O., M.D. Envita Medical Centers

Additional Information:
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Responsible Party: Santo Prato, N.M. / President, Envita Medical Center, Inc. Identifier: NCT00909558     History of Changes
Other Study ID Numbers: E001-08
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010
Keywords provided by Envita Medical Center, Inc.:
metastatic malignancies
tumor markers
breast cancer
hepatocellular cancer
squamous cell lung cancer
pancreatic cancer
colon cancer
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Pancreatic Neoplasms
Colonic Neoplasms
Liver Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Colonic Diseases
Physiological Effects of Drugs
Carcinoma, Hepatocellular
Genital Diseases, Male
Prostatic Diseases
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Intestinal Diseases