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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


Phase 1
18 Years
80 Years
Not Enrolling
Both
Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer, Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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?

Outcome Time Frame:

5 -15 Weeks

Safety Issue:

No

Principal Investigator

David Korn, D.O., M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Envita Medical Centers

Authority:

United States: Food and Drug Administration

Study ID:

E001-08

NCT ID:

NCT00909558

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Glioma
  • Hepatocellular Cancer
  • Squamous Cell Lung Cancer
  • Pancreatic Cancer
  • Colon Cancer
  • Prostate Cancer
  • metastatic malignancies
  • tumor markers
  • chemotherapy
  • cancer
  • breast cancer
  • glioma
  • hepatocellular cancer
  • squamous cell lung cancer
  • pancreatic cancer
  • colon cancer
  • prostate cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Glioma
  • Liver Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms

Name

Location

Envita Medical CentersScottsdale, Arizona  85260