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Cancer Vaccine
Dendritic Cell Vaccine + Immunotherapy for Brain Tumor
Phase 1
Waitlist Available
Led By Anthony C Wang
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new treatment for brain tumors that has come back or is getting worse. The treatment includes a vaccine made from the patient's own white blood cells and immunotherapy drugs.
Who is the study for?
This trial is for people aged 13-60 with a specific brain tumor (Diffuse Hemispheric Glioma, H3 G34-mutant) that's returned or worsened. They must be scheduled for tumor removal surgery and have good organ function. Women of childbearing age need a negative pregnancy test and must use birth control. Participants can't join if they've had certain recent treatments, live vaccines, other cancers within 3 years, severe allergies to the study drugs, active infections or autoimmune diseases.Check my eligibility
What is being tested?
The trial tests a personalized vaccine made from patients' white blood cells combined with immunotherapy drugs nivolumab and ipilimumab against this aggressive brain tumor. The treatment aims to boost the immune system's response to fight cancer cells more effectively. This approach follows surgical resection of the tumor.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms from the vaccine, and typical immunotherapy-related issues like fatigue, skin rash or itching. Nivolumab and Ipilimumab might also cause inflammation in various organs which could lead to more serious conditions if not managed properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Increased tumor-infiltrating lymphocyte (TIL) density
Oligoclonal T cell expansion
Side effects data
From 2016 Phase 2 trial • 60 Patients • NCT0009622693%
Fatigue
81%
Dyspnea
72%
Cough
67%
Hemoglobin
65%
Leukopenia NOS
61%
Nausea
60%
Anorexia
60%
Hyperglycemia NOS
58%
Dysphagia
56%
Esophagitis NOS
53%
Dermatitis radiation NOS
49%
Peripheral sensory neuropathy
46%
Weight decreased
44%
Constipation
44%
Alopecia
39%
Neutrophil count
35%
Pneumonitis NOS
33%
Chest pain
32%
Skin hyperpigmentation
30%
Platelet count decreased
30%
Chest wall pain
28%
Hypoalbuminemia
26%
Hyponatremia
25%
Pleural effusion
25%
Diarrhea NOS
25%
Lymphopenia
23%
Dyspepsia
23%
Vomiting NOS
21%
Aspartate aminotransferase increased
21%
Arthralgia
21%
Insomnia
19%
Sinus tachycardia
19%
Alanine aminotransferase increased
19%
Dehydration
19%
Hypocalcemia
19%
Myalgia
19%
Pain - Other
18%
Atelectasis
18%
Pneumothorax NOS
18%
Pericardial effusion
18%
Supraventricular arrhythmia NOS
18%
Hypokalemia
18%
Pyrexia
18%
Esophageal pain
16%
Blood alkaline phosphatase increased
16%
Hyperkalemia
16%
Dysgeusia
14%
Pharyngolaryngeal pain
14%
Hypomagnesemia
14%
Back pain
14%
Dizziness
14%
Headache
14%
Pruritus
12%
Pulmonary fibrosis
12%
Blood/bone marrow - Other
12%
Dry skin
12%
Sweating increased
12%
Hypersensitivity NOS
11%
Laryngitis NOS
11%
Hypoxia
11%
Radiation recall syndrome
11%
Metabolic/laboratory - Other
11%
Pain in extremity
11%
Dermatitis exfoliative NOS
11%
Depression
11%
Hypotension NOS
9%
Pulmonary/upper respiratory - Other
9%
Blood bilirubin increased
9%
Dry mouth
9%
Stomatitis
9%
Blood creatinine increased
9%
Anxiety
9%
Dermatology/skin - Other
9%
Thrombosis
7%
Hot flushes NOS
7%
Bronchospasm
7%
Edema: limb
7%
Hypermagnesemia
7%
Bone pain
7%
Pollakiuria
7%
Rigors
5%
Rhinitis allergic NOS
5%
Epistaxis
5%
Prolonged chest tube drainage or air leak after pulmonary resection
5%
Vision blurred
5%
Gastritis NOS
5%
Mucositis/stomatitis (functional/symptomatic): Esophagus
5%
Blood bicarbonate decreased
5%
Hypercalcemia
5%
Hypophosphatemia
5%
Ataxia
5%
Muscle weakness NOS
5%
Peripheral motor neuropathy
5%
Confusional state
2%
Colonic obstruction
2%
Arrhythmia NOS
2%
Ocular/visual - Other
2%
Ileus paralytic
2%
Abdominal distention
2%
Myocardial ischemia
2%
Serum sickness
2%
Anal infection NOS
2%
Gingival infection
2%
Infection with normal ANC or Grade 1 or 2 neutrophils: Wound
2%
Erythema multiforme
2%
Syncope
2%
Urinary retention
2%
Acute respiratory distress syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation, Surgery, Chemotherapy
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort II Arm C (ppDC, nivolumab)Experimental Treatment3 Interventions
Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.
Group II: Cohort II Arm A (ppDC, placebo)Experimental Treatment3 Interventions
Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.
Group III: Cohort I Arm C (ppDC, nivolumab, ipilimumab)Experimental Treatment6 Interventions
Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.
Group IV: Cohort I Arm B (placebo, nivolumab, ipilimumab)Placebo Group6 Interventions
Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.
Group V: Cohort I Arm A (ppDC, placebo)Placebo Group5 Interventions
Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID in both arms with poly ICLC IM on day -10 and placebo IV on day -9 prior to standard of care surgical resection.
Group VI: Cohort II Arm B (placebo, nivolumab)Placebo Group3 Interventions
Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboxymethylcellulose
FDA approved
Ipilimumab
FDA approved
Leukapheresis
2016
Completed Phase 2
~690
Nivolumab
FDA approved
Placebo Administration
2018
Completed Phase 3
~2540
Resection
2021
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,060 Total Patients Enrolled
Anthony C WangPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am younger than 13 or older than 60.I am currently being treated for an infection.I have undergone HLA testing.I have been treated with specific immune therapy drugs before.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have an active tuberculosis infection.It has been over 23 days since my last chemotherapy session.My blood clotting time is normal or managed if I'm on blood thinners.It has been over a week since my last stereotactic biopsy.I cannot receive gadolinium contrast due to kidney issues.It has been more than 42 days since my last nitrosurea treatment.I have a history of hepatitis B or active hepatitis C.It has been more than 14 days since my last surgery.My cancer has come back more than twice after treatment.I have recovered from any major surgery before starting the study treatment.I am scheduled for surgery to remove as much of the cancer as possible.My liver function tests are within the required range.My kidney function, measured by creatinine or GFR, is within the required range.I am mostly active and can care for myself.I have had or currently have lung inflammation treated with steroids.It's been over 12 weeks since my last radiotherapy, or I have confirmed tumor growth since then.I am between 13 and 60 years old and have a confirmed diagnosis of DHG.I have another cancer that is getting worse or was treated in the last 3 years.I had radiotherapy over 12 weeks ago, recovered from side effects, and didn't have lung inflammation.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I can provide a tissue sample from my high-grade brain tumor for testing.I have not received a live vaccine in the last 30 days.I am not pregnant and agree to use birth control during and after the study.My blood clotting time is normal or managed with medication.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I Arm C (ppDC, nivolumab, ipilimumab)
- Group 2: Cohort I Arm B (placebo, nivolumab, ipilimumab)
- Group 3: Cohort I Arm A (ppDC, placebo)
- Group 4: Cohort II Arm A (ppDC, placebo)
- Group 5: Cohort II Arm B (placebo, nivolumab)
- Group 6: Cohort II Arm C (ppDC, nivolumab)
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any openings available for participation in this scientific experiment?
"Clinicaltrials.gov indicates that this medical trial has ceased the recruitment of patients, with its original posting on January 1st 2023 and most recent edit occuring on October 13th 2022. However, there are currently 355 other clinical trials actively searching for participants today."
Answered by AI
Is there a certain demographic of participants that is eligible for this scientific experiment?
"This medical investigation is in search of 15 patients aged 13 to 60 who have been diagnosed with glioma. Furthermore, the following requirements must be met: A pre-trial urine or serum pregnancy test needs to take place within 72 hours for female participants capable of childbearing and they are expected to use contraception during their involvement and up to 120 days after their last dosage; Informed consent (and written assent from minors) must be provided by participant or legal representative if applicable; At least 14 days since prior surgical resection, 7 days since prior stereotactic biopsy, 12 weeks since radiotherapy unless there’s histological"
Answered by AI
Has the Resection procedure been given regulatory approval by the FDA?
"Resection's safety is cautiously evaluated with a score of 1 since this is an initial Phase 1 trial, which implies that limited data exists to support its efficacy and security."
Answered by AI
Does this trial extend to those aged eighty or above?
"Participants must be between 13 and 60 years old to qualify for this clinical trial."
Answered by AI
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