Clinical trial NCT00909558: Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer
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 type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Breast Cancer
Glioma
Hepatocellular Cancer
Squamous Cell Lung Cancer
Pancreatic Cancer
Colon Cancer
Prostate Cancer
Keywords: metastatic malignancies
tumor markers
chemotherapy
cancer
breast cancer
glioma
hepatocellular cancer
squamous cell lung cancer
pancreatic cancer
colon cancer
prostate cancer
Lead sponsor: Envita Medical Center, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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?
timeFrame: 5 -15 Weeks
Secondary outcomes:
measure: 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?
timeFrame: 5 - 15 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Envita Medical Centers
state: Arizona
Study officials:
affiliation: Envita Medical Centers
name: David Korn, D.O., M.D.
role: PRINCIPAL_INVESTIGATOR
References: