D2C7-IT With Atezolizumab for Recurrent Gliomas
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|ClinicalTrials.gov Identifier: NCT04160494|
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: D2C7-IT (6920 ng/mL via convection-enhanced delivery) Drug: Atezolizumab (1200 mg every three weeks)||Phase 1|
Approximately eighteen patients with recurrent WHO grade IV malignant glioma will receive atezolizumab and D2C7-IT followed by possible surgical resection of their recurrent tumor, at the discretion of the treating neurosurgeon, and continued atezolizumab to determine the impact of the combination of D2C7-IT and atezolizumab on safety. D2C7-IT will be delivered intratumorally by Convection Enhanced Delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor.
Atezolizumab will be administered according to the FDA-approved dosing schedule of 1200 mg intravenously every 3 weeks, beginning ~2 weeks after the D2C7-IT infusion.
Patients who choose to undergo surgical resection will have their surgery ~4 weeks after D2C7-IT administration. If, at the time that surgery is anticipated, the patient is determined by the neurosurgeon to have contraindications for surgery and does not undergo surgical resection, or chooses not to undergo surgical resection, the patient will continue with adjuvant atezolizumab and remain on-study.
Toxicity will be carefully monitored for at least a year after D2C7-IT treatment, or at least 30 days after the final dose of atezolizumab if the patient continues atezolizumab on-study for longer than a year post-D2C7-IT. Of particular interest will be the incidence of adverse events that occur during the first 28 days after D2C7-IT treatment and the inflammatory events that occur during the first year after D2C7-IT treatment. The most common risks associated with D2C7-IT are effects related to tumor necrosis, neurologic changes (including changes in function, new or increased seizures, swelling of the brain, and injury to blood vessels), effects related to catheter placement or removal, and effects related to fluid infusion into the brain. The most common risks associated with atezolizumab are fatigue, decreased appetite, diarrhea, and nausea. Because atezolizumab works with the immune system, it can cause the immune system to attack normal organs or tissue and affect how they work.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of D2C7-IT in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2025|
Experimental: D2C7-IT + Atezolizumab
Single D2C7-IT infusion (6920 ng/mL) plus atezolizumab intravenous (IV) infusions at a dose of 1200 mg every three weeks for up to two years
Drug: D2C7-IT (6920 ng/mL via convection-enhanced delivery)
Drug: Atezolizumab (1200 mg every three weeks)
programmed cell death ligand 1 (PD-L1) blocking antibody
Other Name: Tecentriq
- Proportion of patients with an unacceptable adverse event [ Time Frame: 2 years ]An unacceptable adverse event includes any Grade 3 or any Grade 4 toxicity that is not reversible within 2 weeks, any life-threatening event, or any treatment-related death. Also included are any grade 2 or higher serious autoimmune toxicities, particularly those affecting vital organs (e.g. cardiac, renal, CNS) if it occurs within 2 weeks of any protocol treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160494
|Contact: Dina Randazzo, DOfirstname.lastname@example.org|
|Contact: Stevie Threattemail@example.com|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Dina Randazzo, DO||Duke University|