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Cancer Vaccine

Vaccine Therapy for Glioblastoma (ATTAC-II Trial)

Phase 2
Waitlist Available
Led By Maryam Rahman, MD
Research Sponsored by Immunomic Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death, assessed up to 24 months
Awards & highlights

ATTAC-II Trial Summary

This trial is testing whether a dendritic cell vaccine can help treat glioblastoma by being given with stronger doses of chemotherapy.

Eligible Conditions
  • Glioblastoma
  • Malignant Glioma

ATTAC-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death, assessed up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in median overall survival
Secondary outcome measures
Change in progression-free survival
Changes in immune response

Side effects data

From 2020 Phase 2 trial • 64 Patients • NCT02366728
100%
Hypertension
67%
Lymphocyte count decreased
67%
Platelet count decreased
67%
Hyperglycemia
67%
Anemia
56%
CD4 lymphocytes decreased
44%
Skin and subcutaneous tissue disorders - Other, Specify (RASH)
44%
Neutrophil count decreased
44%
White blood cell decreased
44%
Hypocalcemia
33%
Upper respiratory infection
33%
Hyponatremia
33%
Sinusitis
33%
Aspartate aminotransferase increased
22%
Memory impairment
22%
Nausea
22%
Fatigue
22%
Injection site reaction
22%
Hypoglycemia
22%
Hypokalemia
22%
Movements involuntary
22%
Paresthesia
22%
Urinary incontinence
22%
Creatinine increased
22%
Seizure
22%
Alanine aminotransferase increased
22%
Hypoalbuminemia
22%
Arthralgia
11%
Skin and subcutaneous tissue disorders - Other, Specify (SKIN "SORENESS" AROUND L EYE)
11%
Muscle weakness left-sided
11%
Infusion related reaction
11%
Injury, poisoning and procedural complications - Other, Specify (LEFT SHIN WOUND)
11%
Pyramidal tract syndrome
11%
Colonic perforation
11%
Blood and lymphatic system disorders - Other, Specify (SWOLLEN LYMPH NODES BILATERAL NECK)
11%
Sinus tachycardia
11%
Eye disorders - Other, Specify (DIFFICULTY WITH DEPTH PERCEPTION)
11%
Constipation
11%
Dyspepsia
11%
Vomiting
11%
Edema limbs
11%
Pain
11%
Wound complication
11%
Dehydration
11%
Glucose intolerance
11%
Hypercalcemia
11%
Confusion
11%
Skin and subcutaneous tissue disorders - Other, Specify (PIMPLE LIKE AREA NEAR SITE OF INJECTION)
11%
Dry skin
11%
Generalized muscle weakness
11%
Ear pain
11%
Hydrocephalus
11%
Allergic rhinitis
11%
Headache
11%
Urinary retention
11%
Facial muscle weakness
11%
Localized edema
11%
Mucosal infection
11%
Otitis media
11%
Injury, poisoning and procedural complications - Other, Specify (L ELBOW INJURY FALLING OUT OF BED)
11%
Hypermagnesemia
11%
Dizziness
11%
Tremor
11%
Insomnia
11%
Hematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group III: Basiliximab and Tetanus Pre-conditioning
Group I: Unpulsed DC Pre-conditioning
Group II: Tetanus Pre-conditioning

ATTAC-II Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: pp65-shLAMP DC with GM-CSF and TdExperimental Treatment2 Interventions
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Group II: pp65-flLAMP DC with GM-CSF and TdExperimental Treatment2 Interventions
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Group III: unpulsed PBMC and SalinePlacebo Group2 Interventions
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pp65-shLAMP DC with GM-CSF
2016
Completed Phase 2
~180
pp65-flLAMP DC with GM-CSF
2016
Completed Phase 2
~180
Td
2016
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

Immunomic Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
301 Total Patients Enrolled
2 Trials studying Glioblastoma
16 Patients Enrolled for Glioblastoma
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,530 Total Patients Enrolled
10 Trials studying Glioblastoma
308 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,492 Total Patients Enrolled
322 Trials studying Glioblastoma
22,940 Patients Enrolled for Glioblastoma

Media Library

pp65-flLAMP DC with GM-CSF (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02465268 — Phase 2
Glioblastoma Research Study Groups: pp65-flLAMP DC with GM-CSF and Td, unpulsed PBMC and Saline, pp65-shLAMP DC with GM-CSF and Td
Glioblastoma Clinical Trial 2023: pp65-flLAMP DC with GM-CSF Highlights & Side Effects. Trial Name: NCT02465268 — Phase 2
pp65-flLAMP DC with GM-CSF (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02465268 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts for this clinical trial ongoing?

"From what is detailed on clinicaltrials.gov, it appears as though this study is still recruiting patients. The listing was first put up on August 1st, 2016 and the most recent update was November 2nd, 2022."

Answered by AI

What is the FDA's opinion of Td?

"While there is some evidence supporting the safety of Td, it does not have any data demonstrating efficacy. Therefore, it received a score of 2."

Answered by AI

What other scientific research has been done on Td?

"As of the current moment, there are 19 ongoing clinical trials studying Td. Out of those 19, 8 are Phase 3 trials. The majority of these studies for Td are based in Randwick, New South Wales; however, there are a total of 491 locations running trials for this treatment globally."

Answered by AI

Does this research project have any precedents?

"Td has been under scrutiny since 2016 when the first trial, which was sponsored by Pharmacyclics LLC., took place. The initial study included 42 participants and after favorable results Td received Phase 2 drug approval in 2016. As of now, there are 19 active trials being conducted for Td in 162 different cities located across 13 countries."

Answered by AI

How many people are enrolling in this clinical trial in total?

"Yes, the most recent information from clinicaltrials.gov states that this study is actively looking for participants. The trial was first advertised on August 1st, 2016 and updated November 2nd, 2020. They are enrolling a total of 175 patients at 2 locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
2016. "Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02465268.
~20 spots leftby Apr 2025
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