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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00909558
• Other study ID #: E001-08
• Status: Suspended
• Phase: Phase 1
• First received: May 27, 2009
• Last updated: February 23, 2010
• Start date: May 2009

Study information

• Verified date: February 2010
• Source: Envita Medical Center, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Glioma
• Hepatocellular Cancer
• Liver Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Squamous Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Envita Medical Centers	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Envita Medical Center, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?		5 -15 Weeks	No
Secondary	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?		5 - 15 weeks	Yes