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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

All Individual Drugs Already Approved

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Increased tumor-infiltrating lymphocyte (TIL) density

Oligoclonal T cell expansion

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00096226

93%

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%

Lymphopenia

25%

Diarrhea NOS

25%

Pleural effusion

23%

Dyspepsia

23%

Vomiting NOS

21%

Aspartate aminotransferase increased

21%

Arthralgia

21%

Insomnia

19%

Sinus tachycardia

19%

Pain - Other

19%

Alanine aminotransferase increased

19%

Dehydration

19%

Hypocalcemia

19%

Myalgia

18%

Esophageal pain

18%

Pericardial effusion

18%

Supraventricular arrhythmia NOS

18%

Pyrexia

18%

Hypokalemia

18%

Atelectasis

18%

Pneumothorax NOS

16%

Blood alkaline phosphatase increased

16%

Hyperkalemia

16%

Dysgeusia

14%

Hypomagnesemia

14%

Back pain

14%

Headache

14%

Dizziness

14%

Pharyngolaryngeal pain

14%

Pruritus

12%

Blood/bone marrow - Other

12%

Pulmonary fibrosis

12%

Dry skin

12%

Sweating increased

12%

Hypersensitivity NOS

11%

Radiation recall syndrome

11%

Metabolic/laboratory - Other

11%

Pain in extremity

11%

Depression

11%

Hypoxia

11%

Laryngitis NOS

11%

Dermatitis exfoliative NOS

11%

Hypotension NOS

Dry mouth

Stomatitis

Blood bilirubin increased

Blood creatinine increased

Anxiety

Thrombosis

Pulmonary/upper respiratory - Other

Dermatology/skin - Other

Edema: limb

Hypermagnesemia

Bone pain

Pollakiuria

Bronchospasm

Hot flushes NOS

Rigors

Gastritis NOS

Vision blurred

Mucositis/stomatitis (functional/symptomatic): Esophagus

Blood bicarbonate decreased

Hypercalcemia

Hypophosphatemia

Muscle weakness NOS

Peripheral motor neuropathy

Ataxia

Confusional state

Epistaxis

Rhinitis allergic NOS

Prolonged chest tube drainage or air leak after pulmonary resection

Arrhythmia NOS

Myocardial ischemia

Abdominal distention

Colonic obstruction

Ocular/visual - Other

Ileus paralytic

Serum sickness

Infection with normal ANC or Grade 1 or 2 neutrophils: Wound

Anal infection NOS

Gingival infection

Urinary retention

Acute respiratory distress syndrome

Erythema multiforme

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Chemoradiation, Surgery, Chemotherapy

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

~710