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Cancer Vaccine
D2C7-IT + 2141-V11 for Glioblastoma
Phase 1 & 2
Recruiting
Led By Daniel Landi, MD
Research Sponsored by Darell Bigner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial tests a new treatment for a type of brain tumor using drugs injected into the brain and under the skin.
Who is the study for?
Adults over 18 with newly diagnosed glioblastoma, a type of brain tumor, who've had surgery to remove it but still have some remaining disease. They must be in good health otherwise, with proper organ function and blood counts, not on high doses of steroids or anticoagulants that can't be paused for surgery. Participants should not be pregnant or breastfeeding and must agree to use birth control if they can have children.Check my eligibility
What is being tested?
The trial is testing two investigational drugs: D2C7-IT given once inside the brain after surgery and 2141-V11 injected multiple times under the skin near lymph nodes. The study aims to see how safe these treatments are and how well they work against glioblastoma when combined with standard radiation therapy.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to albumin content in drugs, liver issues leading to jaundice or coagulation problems, worsening muscle weakness from steroid treatment, immune system complications requiring recent immunomodulatory therapy, infections needing IV treatment, severe heart or lung conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
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).
Safety as measured by 6-month progression-free survival (PFS6)
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
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: D2C7-IT + 2141-V11Experimental Treatment2 Interventions
Single D2C7-IT intratumoral infusion (6920 ng/mL in 36 mL) over 72 hours followed by single 2141-V11 infusion (5 dose levels) over 7 hours followed by an injection of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor at week 2, radiation, and further injections of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D2C7-IT
2015
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Darell BignerLead Sponsor
6 Previous Clinical Trials
221 Total Patients Enrolled
1 Trials studying Glioblastoma
92 Patients Enrolled for Glioblastoma
Rockefeller UniversityOTHER
158 Previous Clinical Trials
16,307 Total Patients Enrolled
1 Trials studying Glioblastoma
36 Patients Enrolled for Glioblastoma
Daniel Landi, MDPrincipal InvestigatorDuke University
9 Previous Clinical Trials
283 Total Patients Enrolled
5 Trials studying Glioblastoma
85 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of brain tumor (glioblastoma) that has been surgically removed but still shows signs on scans.I do not have severe health issues that could interfere with the treatment.My platelet count is high enough for tests and procedures.I am not pregnant or breastfeeding.I am 18 years old or older.I am at risk of a severe brain condition due to pressure increase.I am able to care for myself and perform normal activities with minimal assistance.I can undergo standard radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: D2C7-IT + 2141-V11
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial still available?
"According to the clinicaltrials.gov website, enrollment for this medical trial has concluded; it was first posted on February 1st 2023 and last updated seven days later. However, there are 445 other active studies recruiting patients at present."
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