Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT04922723
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered by IV infusion to subjects in combination with current therapeutic strategies of surgical resection followed by a course of Temozolomide and radiation therapy.

Study Details

TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and its microenvironment. Daratumumab is commercially available, is safe and well tolerated when combined with alkylating chemotherapy, radiation therapy and has attained therapeutic CSF levels. Thus, the addition of Daratumumab to the frontline treatment regimen of GBM can potentially have a significant clinical benefit. Approximately 16 subjects will be enrolled in this trial. Up to 6 will be enrolled in the phase I part and 10 to 13 in the phase II part to come up with a total of 16 patients with 2 phases combined.

Key Dates

Start date
Oct 3, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Daratumumab, IV, 16 mg/KG - 1 dose prior to surgery or biopsy; Weeks 1 - 8 = 1 dose weekly; Weeks 9 - 24 = 1 dose every other week; Weeks 25 onward (determined by disease progression) = 1 dose every 4 weeks

Primary Outcome Measure

Dose Limiting Toxicity (DLT) rate of Daratumumab [ Time Frame: Up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
West Virginia University Cancer Institute Mary Babb Randolph Cancer CenterMorgantownWest Virginia26506-

Find similar trials in Morgantown, WV

By condition
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By specialty
OncologyNeuro-oncology
By research site
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center· Morgantown, WV

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