Phase 1 Trial of D2C7-IT and 2141-V11 for Recurrent Malignant Glioma
This study is testing two drugs, D2C7-IT and 2141-V11, in people with recurrent malignant glioma (a type of brain tumor). The drugs are given directly into the tumor. Researchers want to see how safe this combination is and what side effects might occur. You may be able to join if you are 18 or older and have a specific type of recurrent malignant glioma. The study is looking at how many patients experience side effects from the drugs and the devices used to deliver them. The current status of the study is unclear.
- Study design
- This is a Phase 1 interventional study aiming to enroll up to 90 participants. It is designed to test the safety of D2C7-IT and 2141-V11 when given together.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures side effects within 14 to 28 days after catheter removal or device placement.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Annick Desjardins, MD,FRCPC · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- Proportion of patients with dose-limiting toxicity (DLT) within each dose level28 days after catheter removal
DLTs are defined as any of the following events that are at least possibly, probably, or definitely attributable to study treatment (2141-V11 or the combination of D2C7-IT and 2141-V11) during dose escalation. As the optimal dose of D2C7-IT in monotherapy has been well established, only toxicity starting or increasing in grade at any time after the start of 2141-V11 will be considered for DLT definition.
- Proportion of patients with unacceptable toxicity resulting from injections of 2141-V11 in the CPL area ipsilateral to the tumor28 days after catheter removal
For the purpose of monitoring adverse events occurring with perilymphatic injections of 2141-V11, we will define an unacceptable toxicity as any adverse event that satisfies the definition of DLT.
- The proportion of patients with Tumor Monorail Device (TMD)-related unacceptable adverse event14 days following TMD placement
Unacceptable adverse events following TMD placement are defined as follows * Cerebral edema (grade 3 or higher) due to device implantation * New neurological symptoms (grade 3 or higher) that do not resolve within 2 weeks and not due to tumor progression * Device-related infection (grade 3 or higher) * Intracranial hemorrhage (grade 3 or higher) * Tumor mis-migration (extracranial extension)