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Tests treatment safety and results for GBM
Official title Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients
ClinicalTrials.gov ID: NCT04115761
What this study is testing
What is autologous dendritic cells?
autologous dendritic cells is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for gbm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75
You may be able to join if
- Stage I (Pre-screening)
- Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.
- Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo...
- Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).
- Only one GBM tumor number.
You likely can't join if
- Stage I (Pre-screening)
- Number of GBM is more than one
- Patient who has participated in other investigational studies within 4 weeks prior to pre-screening
- Patient with known or suspected hypersensitivity to ADCV01 or its excipients
- Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and...
- Patient has acute infectious disease or acute cardiovascular disease; clinically manifest myocardial insufficiency or history of myocardial...
See the full eligibility criteria
Who can join
- Stage I (Pre-screening)
- Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.
- Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo craniotomy tumor excision, and are willing to preserve the resected tumor...
- Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).
- Only one GBM tumor number.
- Patients must be able to understand and sign the informed consent documents and aware of the investigational nature of the study.
- Patients have the expected life expectancy of \> 12 weeks at the pre-screening visit as judged by the investigator.
- Patients with stable vital sign and KPS ≥ 70 at the pre-screening visit.
- Patients with adequate renal function at the pre-screening visit: serum creatinine \ 30 mL/min
- Patients with adequate liver function at the pre-screening visit: AST, ALT, and ALP ≤ 3× upper limit of normal (ULN); and total bilirubin \< 3 mg/dL
- Patients with prothrombin time and activated partial thromboplastin time ≤ 1.5× ULN at the pre-screening visit
- Patients with adequate hematopoietic function at the prescreening and before administration of study medication
- Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
- Platelets ≥ 100,000 counts/μL
- Total white blood cell (WBC) ≥ 2,000 cells/μL
- Hemoglobin ≥ 8 g/dL
- All male and female patients with child-bearing potential (between puberty and 2 years after menopause) must be practicing sexual abstinence and be willing to continue to use a medically acceptable form of birth control...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, thermal symptom post-ovulation methods) and withdrawal are not acceptable...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before administration of study treatment. In case of oophorectomy alone, only when the...
- Male sterilization (at least 6 months prior to screening). For female people in the study, the vasectomized male partner should be the sole partner for that subject
- Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3): d.1 Use of oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have...
- Patients agree to be in compliance with treatment plan as planned in the clinical protocol. Stage II (Screening/Randomization) In addition to fulfill the criteria in Stage I, following criteria should be met to be...
- Patients' resected brain tumors are pathologically confirmed cases of the IDH-1 wild-type glioblastoma, and patients are willing to do monocyte-collecting apheresis at the screening/randomization visit.
- At the screening/randomization visit, patients' resected brain tumors are confirmed of low PD-1+/ CD8+ ratio (ratio \<0.21).
- Residual tumor with less than 25% contrast-enhancing mass on post-surgical brain MRI (within 2 days post-operation) as assessed by the neurosurgeon and/or radiologist.
What rules you out
- Stage I (Pre-screening)
- Number of GBM is more than one
- Patient who has participated in other investigational studies within 4 weeks prior to pre-screening
- Patient with known or suspected hypersensitivity to ADCV01 or its excipients
- Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and Stevens-Johnson syndrome) to dacarbazine (DTIC) or any components of...
- Patient has acute infectious disease or acute cardiovascular disease; clinically manifest myocardial insufficiency or history of myocardial infarction during the past 6 months prior to prescreening; or has active...
- Patient has clinically significant immuno-compromised condition (other than that related to the use of corticosteroids), is human immunodeficiency virus positive (anti-HIV and nucleic acid test) or medical condition...
- Patient with active rheumatic disease or other collagen vascular disease, or is with active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barre syndrome). Patients with...
- Patients with psoriasis requiring systemic therapy, or conditions expected to recur in the presence of an external trigger
- Patient with syphilis, acute HBV, HCV (except hepatitis carriers), HTLV-I/II, CMV, or an increased risk (or has been diagnosed) for human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob...
- Patient with history of coagulation disorder associated with bleeding or recurrent thrombotic events
- Patient with medical, social, or psychological factors interfering with compliance of the study
- Female patient who is lactating, pregnant, or planned to be pregnant
- Inability to undergo MRI for any reason
- History of malignancy other than glioma that is not stable in the past 5 years prior to pre-screening (informed consent form signing date)
- Patient not suitable to participate the trial as judged by the investigator. Stage II (Screening/Randomization) The patient will be no longer eligible to participate the study if he/she met any of the following criteria:
- GBM patients with high PD-1+/CD8+ ratio ≥ 0.21
- GBM patients with mutant IDH-1
- Residual tumor volume more than 25% of pre-operative tumor size.
The study team makes the final eligibility decision.
Where it's taking place
- Taichung, Non-US, Taiwan
- Taoyuan, Non-US, Taiwan
- Taichung, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taichung, Non-US, Taiwan; Taoyuan, Non-US, Taiwan; Taichung, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.