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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Envita Medical Center, Inc.
ClinicalTrials.gov Identifier:
NCT00909558
First received: May 27, 2009
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Envita Medical Center, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909558

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

No publications provided

Responsible Party: Santo Prato, N.M. / President, Envita Medical Center, Inc.
ClinicalTrials.gov Identifier: NCT00909558     History of Changes
Other Study ID Numbers: E001-08
Study First Received: May 27, 2009
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Envita Medical Center, Inc.:
metastatic malignancies
tumor markers
chemotherapy
cancer
breast cancer
glioma
hepatocellular cancer
squamous cell lung cancer
pancreatic cancer
colon cancer
prostate cancer

Additional relevant MeSH terms:
Lung Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Breast Neoplasms
Liver Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Breast Diseases
Skin Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2014