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
Qualifiers
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
Treatments tested in this trial
- D2C7-IT
- 2141-V11
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov