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Monoclonal Antibodies
D2C7-IT + 2141-V11 for Brain Cancer
Phase 1
Recruiting
Led By Daniel Landi, MD
Research Sponsored by Annick Desjardins, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky Performance Score (KPS) ≥ 70%
At the time of biopsy, prior to administration of D2C7-IT, the presence of recurrent tumor must be confirmed by histopathological analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days after catheter removal
Awards & highlights
Study Summary
This trial is testing a new drug combination for brain cancer.
Who is the study for?
Adults over 18 with recurrent high-grade malignant glioma confirmed by biopsy, able to undergo MRI, and not pregnant or breastfeeding. They must have a good performance status (able to care for themselves), adequate blood counts, normal liver function tests, and agree to use effective contraception if of childbearing potential. Excluded are those with severe medical conditions like active infections or heart disease, recent chemotherapy or immunotherapy within specific time frames, certain prior cancers, autoimmune diseases requiring treatment in the past 3 months, and excessive steroid use.Check my eligibility
What is being tested?
This phase 1 trial is testing a combination of an anti-CD40 monoclonal antibody called 2141-V11 and D2C7-IT in patients who have had their brain tumor come back after initial treatment. The study aims to evaluate the safety of this combo therapy at Duke's Brain Tumor Center.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to antibodies (like fever or chills), issues from immune system activation such as inflammation in different body parts including organs like lungs or liver; fatigue; changes in blood cell counts leading to increased infection risk; bleeding complications; muscle weakness especially if on steroids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
Select...
My recent biopsy confirmed the recurrence of my tumor.
Select...
My kidney function tests are within normal limits.
Select...
My brain tumor is a high-grade glioma confirmed by tissue analysis.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days after catheter removal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days after catheter removal
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with dose-limiting toxicity (DLT) within each dose level
Trial Design
1Treatment groups
Experimental Treatment
Group I: D2C7-IT + 2141-V11Experimental Treatment2 Interventions
Single D2C7-IT intratumoral infusion (4613.2 ng/mL in 36 mL) over 72 hours followed by single 2141-V11 infusion (5 dose levels) over 7 hours
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?
Annick Desjardins, MDLead Sponsor
2 Previous Clinical Trials
61 Total Patients Enrolled
Darell BignerLead Sponsor
6 Previous Clinical Trials
241 Total Patients Enrolled
Rockefeller UniversityOTHER
158 Previous Clinical Trials
16,327 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself but may not be able to do active work.I have worsening muscle weakness and muscle loss in my arms and legs.I haven't had immunotherapy in the last 4 weeks or have recovered from its side effects.I have severe lung disease or my diabetes is not under control.My recent biopsy confirmed the recurrence of my tumor.I have taken more than 4 mg of dexamethasone daily in the last 2 weeks.My tumor has or might have a specific genetic feature, and I've had chemotherapy before.My blood clotting tests are normal, and if I'm on blood thinners, they're managed as per guidelines.My tumor's MGMT promoter is unmethylated, so I haven't had to undergo chemotherapy before this trial.I haven't had chemotherapy or bevacizumab in the last 4 weeks, or if I did, I've recovered from the side effects.I am not currently being treated for cancer, except for early-stage cervical, basal cell, or squamous cell skin cancer.My cancer has spread to my brainstem, cerebellum, or spinal cord and is actively growing.My kidney function tests are within normal limits.I do not have severe heart disease.I have an immunosuppressive disease or HIV.I do not have an active infection needing IV treatment or a fever over 99.5°F.My platelet count is at least 100,000/µl without help, and over 125,000/µl for biopsy procedures.I haven't had radiation therapy in the last 12 weeks, or if I have, my cancer has still grown.You have a serious and ongoing health issue that could interfere with your ability to participate in the study.You are allergic to albumin.I cannot become pregnant or get someone pregnant.I have an autoimmune disease but haven't needed systemic treatment for it in the last 3 months.You are able to have an MRI scan of your brain with a special dye if needed.My brain tumor is a high-grade glioma confirmed by tissue analysis.I am 18 years old or older.I am not pregnant or breastfeeding.I have not used tumor treating fields like Optune in the last week.I haven't finished all standard treatments, including surgery and radiation.
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.
What is the current enrollment quota for this research endeavor?
"Affirmative. The clinicaltrials.gov website reveals that this study is actively searching for volunteers, having been initially posted on July 9th 2021 and recently updated in late July 2022. 30 participants will be enrolled at 1 location."
Answered by AI
Are participants still welcome to join this investigation?
"Affirmative. According to the clinicaltrials.gov database, this trial is currently recruiting patients; it was initially put up on July 9th 2021 and updated lastly on July 27th 2022. The study necessitates 30 participants from a single medical centre."
Answered by AI
Has the FDA sanctioned D2C7-IT for use in medical treatments?
"Our experts at Power rate D2C7-IT's safety as a 1 because it is in the earliest trial phase and there is only scant clinical evidence confirming its efficacy."
Answered by AI
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