Giant Cell GlioblastomaEarly Phase 1NCT03360708
Vaccine Therapy in Treating Patients With Recurrent Glioblastoma
A Early Phase 1 study testing Laboratory Biomarker Analysis and Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine in people with Giant Cell Glioblastoma and Recurrent Glioblastoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Glioblastoma, Recurrent Glioblastoma, Recurrent Gliosarcoma
- What is being tested?
- Laboratory Biomarker Analysis and Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2013to 2 Jun 2021
- Phase
- Early 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
- First or second recurrence of previously histologically confirmed glioblastoma (grade 4 astrocytoma)
- NOTE: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) may be included, primitive neuroectodermal tumor (PNET) variants are excluded; grade 4 oligodendrogliomas or oligoastrocytomas are specifically excluded
- Prior craniotomy and gross total or sub-total resection of tumor at this recurrence NOTE: biopsy of this recurrence alone without attempt at resection does not meet this inclusion criteria (i.e. craniotomy and resection is still required).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500/uL
- Monocytes >= 300/uL
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- Platelets (PLT) >= 100,000/uL
- Hemoglobin (HgB) >= 9.0 g/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN
- Creatinine =< 1.5 x ULN
- Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
- Ability to understand and willingness to sign written informed consent
- Willing to return to Mayo Clinic in Rochester, Minnesota for follow-up
- Willing to provide tissue and blood samples for mandatory correlative research purposes
- Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
Who cannot join
- Prior treatment
- Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
- Surgery =< 2 weeks prior to registration
- Radiotherapy =< 12 weeks prior to registration
- Treatment with bevacizumab or any cytotoxic chemotherapy =< 8 weeks prior to registration
- Any of the following
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- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B (HepB), or hepatitis C (HepC) positive
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of other malignancy other than glioma
- EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or systemic cancer that has been in documented remission for > 10 years
- NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- History of myocardial infarction =< 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Active infection =< 5 days prior to registration or fever >/= 38 degrees Celsius (C) within 5 days prior to registration
- History of tuberculosis or positive purified protein derivative (PPD) test
- Inability or unwillingness to have magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Recurrent Glioblastoma
This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine (autologous dendritic cell [DC] / allogeneic glioblastoma multiforme [GBM] culture lysate vaccination) in glioblastoma patients at first or second recurrence.
SECONDARY OBJECTIVES:
- To document survival and progression-free survival in glioblastoma patients at first or second recurrence receiving autologous DC / allogeneic GBM culture lysate vaccination and compared to historical data.
TERTIARY OBJECTIVES:
- Determine the ability of autologous DC / GBM culture lysate vaccination to generate multiple tumor-associated antigen (TAA)-specific immune responses in GBM patients at first or second recurrence.
II. Assess the relationship between ability tumor induced TAA-specific immune responses and evidence of immunosuppression (peripheral blood immunophenotyping by flow cytometry) following autologous DC / allogeneic GBM culture lysate vaccination in GBM patients at first or second recurrence.
III. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and tumor-associated antigen immune response following autologous DC / allogeneic GBM culture lysate vaccination
IV. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and evidence of immunosuppression at baseline and over time with autologous DC / allogeneic GBM culture lysate vaccination.
OUTLINE:
Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 5 years.
- Being tested
- Laboratory Biomarker Analysis, Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell VaccineBiological
Given ID
| Study group | Role | What they receive |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Biological: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Incidence of significant toxicity will be estimated by the number of patients with significant toxicity divided by the total number of evaluable patients.
Measured: Up to 5 years
Secondary outcomes (7)
Clinical benefit rate
The clinical benefit rate will be estimated by the number of patients with an overall survival for at least 6 months after enrollment or an objective status of CR or PR at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.
Measured: Up to 5 years
Duration of response
Duration of response will be summarized descriptively.
Measured: Date at which the patient?s objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years
Feasibility
The feasibility of the regimen will be estimated by the number of patients who received at least one dose of dendritic cell (DC) injection divided by the total number of patients who received leukapheresis in that arm.
Measured: Up to 5 years
Overall response rate
The overall response rate will be estimated by the number of patients with an objective status of complete response (CR) or partial response (PR) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
Measured: Up to 5 years
Overall survival
Measured: Time from study registration to progression and death due to any cause, assessed up to 5 years
Progression-free survival
Measured: Time from study registration to progression and death due to any cause, assessed up to 5 years
Time to response
Time to response will be summarized descriptively.
Measured: Date of initiation of vaccination treatment to the date at which the patient?s objective status is first noted to be either a CR or PR, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start27 Nov 2013
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell GlioblastomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Parney, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360708
- Sponsor's protocol ID
- MC1772
- Other IDs
- NCI-2017-02159, MC1772
- Status last verified
- Jun 2023
- First submitted
- 28 Nov 2017
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT03360708
- Acronym / sponsor ID
- MC1772
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Nov 2013 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 4 Dec 2017 (actual)
- 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 pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine (autologous dendritic cell [DC] / allogeneic glioblastoma multiforme [GBM] culture lysate vaccination) in glioblastoma patients at first or second recurrence.
SECONDARY OBJECTIVES:
- To document survival and progression-free survival in glioblastoma patients at first or second recurrence receiving autologous DC / allogeneic GBM culture lysate vaccination and compared to historical data.
TERTIARY OBJECTIVES:
- Determine the ability of autologous DC / GBM culture lysate vaccination to generate multiple tumor-associated antigen (TAA)-specific immune responses in GBM patients at first or second recurrence.
II. Assess the relationship between ability tumor induced TAA-specific immune responses and evidence of immunosuppression (peripheral blood immunophenotyping by flow cytometry) following autologous DC / allogeneic GBM culture lysate vaccination in GBM patients at first or second recurrence.
III. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and tumor-associated antigen immune response following autologous DC / allogeneic GBM culture lysate vaccination
IV. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and evidence of immunosuppression at baseline and over time with autologous DC / allogeneic GBM culture lysate vaccination.
OUTLINE:
Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (vaccine therapy) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell VaccinePatients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- First or second recurrence of previously histologically confirmed glioblastoma (grade 4 astrocytoma)
- Prior craniotomy and gross total or sub-total resection of tumor at this recurrence NOTE: biopsy of this recurrence alone without attempt at resection does not meet this inclusion criteria (i.e. craniotomy and resection is still required).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) >= 1500/uL
- Monocytes >= 300/uL
Key exclusion criteria (19 listed)
- Prior treatment
- Any of the following
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B (HepB), or hepatitis C (HepC) positive
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (vaccine therapy) |
| Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell VaccineGiven ID | Biological | Treatment (vaccine therapy) |
Primary outcome
Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 5 years
Incidence of significant toxicity will be estimated by the number of patients with significant toxicity divided by the total number of evaluable patients.
7 secondary outcomes
Clinical benefit rate
Time frame: Up to 5 years
Duration of response
Time frame: Date at which the patient?s objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years
Feasibility
Time frame: Up to 5 years
Overall response rate
Time frame: Up to 5 years
Overall survival
Time frame: Time from study registration to progression and death due to any cause, assessed up to 5 years
Progression-free survival
Time frame: Time from study registration to progression and death due to any cause, assessed up to 5 years
Time to response
Time frame: Date of initiation of vaccination treatment to the date at which the patient?s objective status is first noted to be either a CR or PR, assessed up to 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 28 Jun 2023.
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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.
Ian Parney principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Laboratory Biomarker Analysis and Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine in people with Giant Cell Glioblastoma and Recurrent Glioblastoma, run by Mayo Clinic 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 16 inclusion and 19 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 28 Jun 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (time frame: Up to 5 years). 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 28 Jun 2023.