Adult Diffuse AstrocytomaPhase 2NCT01635283

Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

A Phase 2 study testing tumor lysate-pulsed autologous dendritic cell vaccine and laboratory biomarker analysis in people with Adult Diffuse Astrocytoma and Adult Mixed Glioma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma
What is being tested?: tumor lysate-pulsed autologous dendritic cell vaccine and laboratory biomarker analysis
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2012to 13 May 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol
Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established
Patients must be able to read and understand the informed consent document; patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients must have a Karnofsky performance status (KPS) rating of >= 60 prior to initiating treatment; patients may be enrolled at a KPS of < 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of >= 60 by the initiation of treatment
Hemoglobin >= 9 gm%

Show all 11Show fewer

Absolute granulocyte count >= 1,500
Platelet count >= 100,000/microliter (uL)
Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times institutional normals
Bilirubin =< 1.5mg%
Blood urea nitrogen (BUN) or creatinine =< 1.5 times institutional normals

Who cannot join

Subjects with an active infection
Inability to obtain informed consent because of psychiatric or complicating medical problems
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
History of immunodeficiency (e.g., human immunodeficiency virus [HIV]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy
Subjects with organ allografts
Inability or unwillingness to return for required visits and follow-up exams
Subjects who have an uncontrolled systemic malignancy that is not in remission

Trial locations and contacts

1 site in 1 country.

United States1 site

Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma

The primary purpose of this phase II clinical trial is to determine the safety and effect on survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a treatment for low-grade glioma patients. Other goals of this study are to determine if the vaccine can cause an immune response against patients' cancer cells and slow the growth of their brain tumors

Read the detailed description

PRIMARY OBJECTIVES:

To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.

SECONDARY OBJECTIVES:

To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.

OUTLINE:

Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.

Conditions: Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor, Adult Oligoastrocytoma
Being tested: tumor lysate-pulsed autologous dendritic cell vaccine, laboratory biomarker analysis
Medical subject headings: Astrocytoma, Glioma, Oligodendroglioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tumor lysate-pulsed autologous dendritic cell vaccineBiological
Given ID
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01635283
Study group	Role	What they receive
Treatment (tumor lysate-pulsed autologous dendritic cells)	Experimental	Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28. Receives: Biological: tumor lysate-pulsed autologous dendritic cell vaccine; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
Measured: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.

Secondary outcomes (2)

Overall Survival (OS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.
Measured: The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
Anti-tumor Immune Responses
Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers:
IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing
Measured: Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 201213 May 2016

First posted9 Jul 2012 (estimated)
Study start10 Jan 2012
Primary completion13 May 2016
Study completion13 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adult Diffuse AstrocytomaStudies of the same condition, open and under way.
More trials run by Jonsson Comprehensive Cancer 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01635283
Sponsor's protocol ID: 11-002665
Other IDs: NCI-2012-00980
Status last verified: May 2016
First submitted: 22 Jun 2012
Last updated: 4 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma
Astrocytoma, IDH-Mutant, Grade 2, Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant
Active, not recruitingPhase 3
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Brain and Central Nervous System Tumors, Neurotoxicity
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma

All Adult Diffuse Astrocytoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Low-grade Glioma
ClinicalTrials.gov ID: NCT01635283
Acronym / sponsor ID: 11-002665
Conditions: Adult Diffuse Astrocytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Tumor, Adult Oligoastrocytoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Jonsson Comprehensive Cancer CenterUniversity, hospital or other
Study start: 10 Jan 2012 (actual)
Primary completion: 13 May 2016 (actual)
Study completion: 13 May 2016 (actual)
First posted: 9 Jul 2012 (estimated)
Results: Posted 4 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.

SECONDARY OBJECTIVES:

To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.

OUTLINE:

Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (tumor lysate-pulsed autologous dendritic cells)	Experimental	Biological: tumor lysate-pulsed autologous dendritic cell vaccine, Other: laboratory biomarker analysisPatients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol
Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established
Patients must be able to read and understand the informed consent document; patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients must have a Karnofsky performance status (KPS) rating of >= 60 prior to initiating treatment; patients may be enrolled at a KPS of < 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of >= 60 by the initiation of treatment

Key exclusion criteria (8 listed)

Subjects with an active infection
Inability to obtain informed consent because of psychiatric or complicating medical problems
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
History of immunodeficiency (e.g., human immunodeficiency virus [HIV]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy

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
tumor lysate-pulsed autologous dendritic cell vaccineGiven ID	Biological	Treatment (tumor lysate-pulsed autologous dendritic cells)
laboratory biomarker analysisCorrelative studies	Other	Treatment (tumor lysate-pulsed autologous dendritic cells)

Primary outcome

Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
Time frame: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.
a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status.

2 secondary outcomes

Overall Survival (OS)
Time frame: The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months.
Anti-tumor Immune Responses
Time frame: Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection.

Results and safety

Results posted to the registry on 4 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)	5	1

Primary outcome: Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate

Time frame: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.. Number. Unit: participants

Measure	Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) n = 5
0-6 months	0
7-12 months	1
13-18 months	1
19-24 months	1
25-30 months	0
>30 months	2

Population analysed: Completed the maximum time allowed on study without being affected by Tumor Recurrence or Progression.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The timeframe for adverse event reporting was from the day of the first vaccine treatment until the patient discontinued the study for any reason, up to 44 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells)	0 of 5 (0%)	3 of 5 (60%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Adult Diffuse Astrocytoma

Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
RecruitingPhase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Central Nervous System Neoplasms, Glioblastoma
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma
Astrocytoma, IDH-Mutant, Grade 2, Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant
Active, not recruitingPhase 3
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
Brain and Central Nervous System Tumors, Neurotoxicity
Active, not recruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
Pediatric Solid Tumor, Pediatric Lymphoma

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.

Robert Prins principal investigator

Jonsson Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 8 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 4 Nov 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate (time frame: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01635283.

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 4 Nov 2020.