GliomaPhase 1NCT00694330
Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
A Phase 1 study testing GM-K562 Vaccination in people with Glioma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- GM-K562 Vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Aug 2009
- 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
- Patients must have recurrent malignant glioma, having already been diagnosed with and treated for biopsy-proven glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma or gliosarcoma.
- Patients will already have been treated with external beam irradiation with or without chemotherapy.
- Patients must be able to undergo a MRI.
- A priori clinical indication for open resection/debulking of recurrent malignant glioma.
- At the time of vaccination, patients must be at least 4 weeks from completion of radiotherapy and 4 weeks from cytotoxic chemotherapy.
- Serum absolute neutrophil count greater than or equal to 1500/mm3
Show all 10Show fewer
- Serum platelets greater than or equal to 50,000/mm3
- Serum sodium greater than or equal to 125 mmol/L
- 18 years of age or older
- Karnofsky Performance Score of 60% or greater
Who cannot join
- Uncontrolled active infection
- Pregnancy or nursing mothers
- HIV infection
- Evidence of active infection with Hepatitis B or C
- Concurrent malignancy
- Active or clinically relevant autoimmune disease
Show all 10Show fewer
- Urgent need for surgical decompression (at the time of initial consultation)
- Previous participation in a gene therapy or immunotherapy trial
- Inability to provide informed consent because of altered mental status or mental illness
- Any other medical, surgical or psychiatric condition which could interfere with the patient's inability to comply with protocol regimen
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
This research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.
Read the detailed description
- Participants will undergo a craniotomy (brain surgery) to remove as much of the tumor as possible from their brain. A pathologist will examine the tissue to determine whether the cells are viable. If not, we will not be able to make the vaccine and the participant will not be eligible to proceed with this treatment protocol.
- The dose of the vaccine will be determined by the number of tumor cells that we are able to collect from the surgery. We will also be trying to determine the appropriate number of GM-K562 cells that can be given safely. We will do this by assigning groups of participants to different dose levels of GM-K562.
- For the first three weeks of this study, vaccines will be given once each week. After the first three weeks, vaccines will be given every other week.
- Before the first and after the fourth vaccinations, a small amount of the participants own irradiated tumor cells will be injected under their skin to see if their immune system will react against it. If the participant develops a rash, they may be asked to undergo a small skin biopsy for additional evaluation. These biopsies are optional.
- During the course of the study, we will also be collecting blood samples to evaluate the effect that the vaccinations may have on the immune system. These tests will be done every month.
- Participants will have an MRI once every two months.
- The following tests and procedures will be done before the participant receive the vaccine and every two weeks (During the first month, these will be performed on Days 1, 3 or 4, 15, 29 and 31 or 32): medical history; physical exam; vital signs; neurological exam; routine blood tests; research blood tests.
- Conditions
- Glioma
- Being tested
- GM-K562 Vaccination
- Keywords
- vaccine, GM-K562, malignant glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-K562 VaccinationBiological
Lethally irradiated autologous glioma cells combined with GM-K562 cells as vaccine therapy given once a week for three weeks then every other week.
| Study group | Role | What they receive |
|---|---|---|
| GM-K562 Vaccination | Experimental | Not described Receives: Biological: GM-K562 Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of preparing lethally irradiated autologous glioma cells for use in combination with irradiated GM-K562 cells as vaccination therapy in this patient population.
Measured: 3 years
To determine the safety and biological activity of subcutaneous and intradermal injection of irradiated autologous malignant glioma cells mixed with irradiated GM-CSF producing GM-K562 cells in this patient population.
Measured: 3 years
Secondary outcomes (2)
Progression free survival
Measured: 3 years
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Responsible party
- Principal investigator, William T. Curry, MD, Massachusetts General Hospital
- Investigators
- William Curry, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694330
- Sponsor's protocol ID
- 06-349
- Status last verified
- Mar 2017
- First submitted
- 6 Jun 2008
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor
- ClinicalTrials.gov ID
- NCT00694330
- Acronym / sponsor ID
- 06-349
- Conditions
- Glioma
- Keywords
- vaccine, GM-K562, malignant glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Study start
- Jun 2008 (actual)
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Jun 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.
This research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.
Detailed description
- Participants will undergo a craniotomy (brain surgery) to remove as much of the tumor as possible from their brain. A pathologist will examine the tissue to determine whether the cells are viable. If not, we will not be able to make the vaccine and the participant will not be eligible to proceed with this treatment protocol.
- The dose of the vaccine will be determined by the number of tumor cells that we are able to collect from the surgery. We will also be trying to determine the appropriate number of GM-K562 cells that can be given safely. We will do this by assigning groups of participants to different dose levels of GM-K562.
- For the first three weeks of this study, vaccines will be given once each week. After the first three weeks, vaccines will be given every other week.
- Before the first and after the fourth vaccinations, a small amount of the participants own irradiated tumor cells will be injected under their skin to see if their immune system will react against it. If the participant develops a rash, they may be asked to undergo a small skin biopsy for additional evaluation. These biopsies are optional.
- During the course of the study, we will also be collecting blood samples to evaluate the effect that the vaccinations may have on the immune system. These tests will be done every month.
- Participants will have an MRI once every two months.
- The following tests and procedures will be done before the participant receive the vaccine and every two weeks (During the first month, these will be performed on Days 1, 3 or 4, 15, 29 and 31 or 32): medical history; physical exam; vital signs; neurological exam; routine blood tests; research blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM-K562 Vaccination | Experimental | Biological: GM-K562 Vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have recurrent malignant glioma, having already been diagnosed with and treated for biopsy-proven glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma or gliosarcoma.
- Patients will already have been treated with external beam irradiation with or without chemotherapy.
- Patients must be able to undergo a MRI.
- A priori clinical indication for open resection/debulking of recurrent malignant glioma.
- At the time of vaccination, patients must be at least 4 weeks from completion of radiotherapy and 4 weeks from cytotoxic chemotherapy.
Key exclusion criteria (10 listed)
- Uncontrolled active infection
- Pregnancy or nursing mothers
- HIV infection
- Evidence of active infection with Hepatitis B or C
- Concurrent malignancy
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 |
|---|---|---|
| GM-K562 VaccinationLethally irradiated autologous glioma cells combined with GM-K562 cells as vaccine therapy given once a week for three weeks then every other week. | Biological | GM-K562 Vaccination |
Primary outcome
To determine the feasibility of preparing lethally irradiated autologous glioma cells for use in combination with irradiated GM-K562 cells as vaccination therapy in this patient population.
Time frame: 3 years
To determine the safety and biological activity of subcutaneous and intradermal injection of irradiated autologous malignant glioma cells mixed with irradiated GM-CSF producing GM-K562 cells in this patient population.
Time frame: 3 years
2 secondary outcomes
Progression free survival
Time frame: 3 years
overall survival
Time frame: 5 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 22 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.
William Curry, MD principal investigator
Massachusetts General Hospital
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 GM-K562 Vaccination in people with Glioma, run by Massachusetts General Hospital 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 10 inclusion and 10 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 22 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 preparing lethally irradiated autologous glioma cells for use in combination with irradiated GM-K562 cells as vaccination therapy in this patient population. (time frame: 3 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 22 Jun 2017.