Breast CancerPhase 1NCT00909558
Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer
A Phase 1 study testing Autologous Natural Killer / Natural Killer T Cell Immunotherapy in people with Breast Cancer and Glioma, run by Envita Medical Center, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer, Glioma, Hepatocellular Cancer
- What is being tested?
- Autologous Natural Killer / Natural Killer T Cell Immunotherapy
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer
- Being tested
- Autologous Natural Killer / Natural Killer T Cell Immunotherapy
- Keywords
- metastatic malignancies, tumor markers, chemotherapy, cancer, breast cancer, glioma, hepatocellular cancer, squamous cell lung cancer, pancreatic cancer, colon cancer, prostate cancer
- Medical subject headings
- Breast Neoplasms, Glioma, Liver Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Natural Killer / Natural Killer T Cell ImmunotherapyBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 5 -15 Weeks
Secondary outcomes (1)
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?
Measured: 5 - 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Envita Medical Center, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Korn, D.O., M.D., Principal investigator, Envita Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909558
- Sponsor's protocol ID
- E001-08
- Status last verified
- Feb 2010
- First submitted
- 27 May 2009
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00909558
- Acronym / sponsor ID
- E001-08
- Conditions
- Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer
- Keywords
- metastatic malignancies, tumor markers, chemotherapy, cancer, breast cancer, glioma, hepatocellular cancer, squamous cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Envita Medical Center, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2010 (estimated)
- First posted
- 28 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Natural Killer / Natural Killer T Cell ImmunotherapyThe 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. | Biological | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Korn, D.O., M.D. principal investigator
Envita Medical Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Natural Killer / Natural Killer T Cell Immunotherapy in people with Breast Cancer and Glioma, run by Envita Medical Center, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2010.