D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDarell Bigner
About this trial
The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years of age at the time of entry into the study
Newly diagnosed supratentorial GBM, WHO grade 4, IDH wildtype, MGMT unmethylated (high grade glioma with molecular features of GBM will be eligible under WHO 4 malignant glioma) with residual radiographic non-contrast enhancing disease on the post-2 cycles of adjuvant TMZ MRI amenable to catheter placement. The residual radiographic contrast enhancing disease is ≤ 3 cm in maximal diameter in any plane.
Patient must have completed standard of care radiation therapy (typically 59.4-60 Gy over approximately 6 weeks duration if under 65 years old and a minimum of 40 Gy over 3 weeks duration if 65 years or older) in combination with TMZ and 2 cycles of post-radiation, adjuvant TMZ. For patients known to be MGMT promoter unmethylated prior to start of radiation therapy, patients are not mandated to have received TMZ in combination to radiation therapy prior to participating in this trial.
Karnofsky Performance Score (KPS) > 70%
Disqualifiers
Patients who are pregnant or breast-feeding/chestfeeding
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate
Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)
Patients with known immunosuppressive disease or known human immunodeficiency virus infection
Trial design
Design model
Single group
Treatments tested in this trial
D2C7-IT
DrugD2C7-IT will be dosed at 166,075 ng in 36 mL.
2141-V11
Drug2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: D2C7-IT + 2141-V11Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Median survival defined as the time between initiation of treatment with D2C7-IT in combination with 2141-V11 and death, or last follow up if alive.
Time frame
3 yearsSecondary outcomes
1
Safety as measured by the proportion of patients with unacceptable adverse events due to the combination of D2C7-IT and 2141-V11 administered via CED
Time frame
6 months2
Safety as measured by the proportion of patients with unacceptable adverse events due to pre-radiation therapy administration of cervical perilymphatic injections of 2141-V11, or delayed completion of radiation therapy
Time frame
6 months3
Safety as measured by 6-month progression-free survival (PFS6)
Time frame
6 months4
Median PFS will be reported, which is defined as the median time between initiation of D2C7-IT and 2141-V11 infusion treatment and initial failure (disease progression or death).
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov