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

May 27, 2009
February 23, 2010
May 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00909558 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Glioma
  • Hepatocellular Cancer
  • Squamous Cell Lung Cancer
  • Pancreatic Cancer
  • Colon Cancer
  • Prostate Cancer
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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
24
Not Provided
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909558
E001-08
Yes
Santo Prato, N.M. / President, Envita Medical Center, Inc.
Envita Medical Center, Inc.
Not Provided
Principal Investigator: David Korn, D.O., M.D. Envita Medical Centers
Envita Medical Center, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP