Malignant MelanomaPhase 1NCT00631072
In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
A Phase 1 study testing INKT and GM-CSF in people with Malignant Melanoma, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
The purpose of this research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- INKT and GM-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV melanoma
- ECOG Performance Status 0-1
- Estimated life expectancy of 6 months or greater
- 18 years of age or older
- Adequate renal, hepatic and hematological function as outlined in protocol
- Adequate pulmonary and cardiac function as outlined in protocol
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- Prior therapies must be discontinued at least 4 weeks prior to the leukopheresis to obtain iNKT cells. This does not include palliative surgery or radiation therapy, which may be used prior to leukopheresis or during the interval between leukopheresis and iNKT cell reinfusion
- Melanoma patients must not have brain metastases based on a negative MRI obtained within 4 weeks prior to screening, and must not have a history of brain metastases
- No other significant medical, surgical or psychiatric condition that, in the judgment of the PI, would interfere with compliance to the protocol regimen
Who cannot join
- Pregnant or nursing women
- Active systemic infection, positive HIV, HBV, or HCV serology, or immune deficiency disease
- Autoimmune disease that currently requires systemic therapy with immunosuppressive agents
- Known hypersensitivity to GM-CSF or DMSO
- Other active malignancy other than squamous cell or basal cell of the skin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Trial of in Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
The purpose of this research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. These iNKT cells have been used in laboratory studies and information from these and other research studies suggest that increasing the number of these cells in the blood can stimulate the immune response against tumors.
Read the detailed description
- The first step in the study will be to collect iNKT cells from the participants peripheral blood. For this procedure an intravenous catheter will be used to remove the blood. The white blood cells will be removed from the blood and the red blood cells and plasma will be returned to the participant (leukopheresis).
- We will then purify the iNKT cells from these collected white blood cells, and will grow them in culture plates in the lab under strictly controlled sterile conditions. This can take 4-6 weeks.
- If we are successful in growing the iNKT cells to large enough numbers, they will be divided into 3 equal doses. Participants will receive one dose of these cells by intravenous infusion every 2 weeks or days 1, 15 and 29. A blood sample will be taken immediately before each infusion, and at 1 and 4 hours after each infusion. Participants will be asked to return for blood samples on day 2, 3, 4 and 8 after infusion.
- The initial group of 3-6 participants will not receive any other therapy with the iNKT cell infusions. However, the subsequent group of 6 patients will in addition receive GM-CSF, which can further stimulate the immune system and may increase the effects of the iNKT cells. This medication is administered by subcutaneous injection and will be given daily for 10 days beginning the day of the second and third infusion.
- Participants will be on this research study for about 14 weeks, which includes the time for the cell purification and culture, treatment, and follow-up observation.
- Conditions
- Malignant Melanoma
- Being tested
- INKT, GM-CSF
- Keywords
- iNKT, in vitro autologous iNKT
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INKTBiological
Also called In vitro expanded autologous invariant natural killer T cells
Administered in 3 equal doses by intravenous infusion on days 1, 15 and 29.
GM-CSFDrug
Given subcutaneously once daily for 10 days beginning the second day of the second and third infusion
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF +INKT | Other | INKT will be administered in 3 equal doses by intravenous infusion on days 1, 15 and 29.
GM-CSF will be given subcutaneously once daily for 10 days beginning the second day of the second and third infusion Receives: Biological: INKT; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of isolating and expanding in vitro autologous iNKT cells from cancer patients for therapeutic use.
Measured: 2 years
To assess the safety of treatment with in vitro expanded autologous iNKT cells alone, and in conjunction with GM-CSF.
Measured: 2 years
Secondary outcomes (2)
To assess the biological activity of reinfused in vitro expanded autologous iNKT cells.
Measured: 2 years
To assess the biological activity of reinfused in vitro expanded autologous iNKT cells in conjunction with GM-CSF.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Steven Balk, MD, Dana-Farber Cancer Institute
- Investigators
- Steven Balk, MD, PhD, Principal investigator, Beth Israel Deaconess Medical CenterF. Stephen Hodi, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631072
- Sponsor's protocol ID
- 06-432
- Status last verified
- Jun 2017
- First submitted
- 28 Feb 2008
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of in Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
- ClinicalTrials.gov ID
- NCT00631072
- Acronym / sponsor ID
- 06-432
- Conditions
- Malignant Melanoma
- Keywords
- iNKT, in vitro autologous iNKT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Feb 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Mar 2008 (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 research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. These iNKT cells have been used in laboratory studies and information from these and other research studies suggest that increasing the number of these cells in the blood can stimulate the immune response against tumors.
Detailed description
- The first step in the study will be to collect iNKT cells from the participants peripheral blood. For this procedure an intravenous catheter will be used to remove the blood. The white blood cells will be removed from the blood and the red blood cells and plasma will be returned to the participant (leukopheresis).
- We will then purify the iNKT cells from these collected white blood cells, and will grow them in culture plates in the lab under strictly controlled sterile conditions. This can take 4-6 weeks.
- If we are successful in growing the iNKT cells to large enough numbers, they will be divided into 3 equal doses. Participants will receive one dose of these cells by intravenous infusion every 2 weeks or days 1, 15 and 29. A blood sample will be taken immediately before each infusion, and at 1 and 4 hours after each infusion. Participants will be asked to return for blood samples on day 2, 3, 4 and 8 after infusion.
- The initial group of 3-6 participants will not receive any other therapy with the iNKT cell infusions. However, the subsequent group of 6 patients will in addition receive GM-CSF, which can further stimulate the immune system and may increase the effects of the iNKT cells. This medication is administered by subcutaneous injection and will be given daily for 10 days beginning the day of the second and third infusion.
- Participants will be on this research study for about 14 weeks, which includes the time for the cell purification and culture, treatment, and follow-up observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM-CSF +INKT | Other | Biological: INKT, Drug: GM-CSFINKT will be administered in 3 equal doses by intravenous infusion on days 1, 15 and 29. GM-CSF will be given subcutaneously once daily for 10 days beginning the second day of the second and third infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stage IV melanoma
- ECOG Performance Status 0-1
- Estimated life expectancy of 6 months or greater
- 18 years of age or older
- Adequate renal, hepatic and hematological function as outlined in protocol
Key exclusion criteria (5 listed)
- Pregnant or nursing women
- Active systemic infection, positive HIV, HBV, or HCV serology, or immune deficiency disease
- Autoimmune disease that currently requires systemic therapy with immunosuppressive agents
- Known hypersensitivity to GM-CSF or DMSO
- Other active malignancy other than squamous cell or basal cell of the skin
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 |
|---|---|---|
| INKTAlso: In vitro expanded autologous invariant natural killer T cellsAdministered in 3 equal doses by intravenous infusion on days 1, 15 and 29. | Biological | GM-CSF +INKT |
| GM-CSFGiven subcutaneously once daily for 10 days beginning the second day of the second and third infusion | Drug | GM-CSF +INKT |
Primary outcome
To determine the feasibility of isolating and expanding in vitro autologous iNKT cells from cancer patients for therapeutic use.
Time frame: 2 years
To assess the safety of treatment with in vitro expanded autologous iNKT cells alone, and in conjunction with GM-CSF.
Time frame: 2 years
2 secondary outcomes
To assess the biological activity of reinfused in vitro expanded autologous iNKT cells.
Time frame: 2 years
To assess the biological activity of reinfused in vitro expanded autologous iNKT cells in conjunction with GM-CSF.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
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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.
Steven Balk, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
F. Stephen Hodi, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INKT and GM-CSF in people with Malignant Melanoma, run by Beth Israel Deaconess Medical Center at 2 sites 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the feasibility of isolating and expanding in vitro autologous iNKT cells from cancer patients for therapeutic use. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 9 Jun 2017.