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Immunotoxin
D2C7-IT for Brain Cancer
Phase 1
Waitlist Available
Led By Dan 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 is testing a new cancer treatment to see what dose is effective and safe for patients with a certain type of brain tumor.
Who is the study for?
Adults over 18 with recurrent high-grade brain tumors (WHO grade III or IV malignant glioma) who've had prior treatment, can undergo MRI scans, and agree to use contraception. They must have good performance status and adequate organ function. Excluded are those with certain medical conditions, recent treatments, or severe allergies.Check my eligibility
What is being tested?
The trial is testing D2C7-IT delivered directly into the tumor in the brain to find the safest dose for future studies. Patients will receive a biopsy followed by catheter placement for infusion if recurrent glioma is confirmed.See study design
What are the potential side effects?
While specific side effects of D2C7-IT aren't listed here, similar cancer treatments often cause fatigue, headache, infection risk increase, nausea or vomiting. Side effects depend on individual patient factors and treatment specifics.
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
Maximum tolerated dose (MTD) and/or recommended phase II dose of D2C7-IT
Secondary outcome measures
Association between EGFRvIII and EGFRwt expression and PFS and OS.
Overall survival (OS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: D2C7-ITExperimental Treatment1 Intervention
Recurrent malignant glioma patients will receive D2C7-IT, delivered intratumorally by CED following confirmatory diagnostic biopsy.
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
190 Total Patients Enrolled
Dan Landi, MDPrincipal InvestigatorPreston Robert Tisch Brain Tumor Center at Duke University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious brain condition that needs urgent treatment.You have been taking more than 4mg of dexamethasone per day in the 2 weeks before starting the treatment.You have received certain types of chemotherapy within a specific time period before enrolling in the study.You have another type of cancer that is currently being treated, except for certain types of skin or cervical cancers.Your tumor has spread to certain areas of the brain or is growing in more than one place.You have a history of gradual weakening and wasting of certain muscles caused by long-term steroid use.You have a type of brain tumor called grade III or IV malignant glioma that has come back after treatment.You have been diagnosed with a high-grade malignant brain tumor in the top part of the brain.Before getting the treatment, a biopsy must confirm that the tumor has come back.You can have a brain MRI with and without a special dye.Your white blood cell count is at least 1000 cells per cubic millimeter before the biopsy.You have taken drugs that stop the growth of new blood vessels within 4 weeks before the biopsy.You have a severe allergy to Gadolinium-DTPA. If you have a mild allergy, like a rash, you will be given medicine before getting the contrast agent.You must have a Karnofsky Performance Status (KPS) score of at least 70%.Your platelet count needs to be at least 100,000/µl to be in the study. If you need a biopsy or catheter insertion, your platelet count needs to be at least 125,000/µl to lower the risk of bleeding in the brain. If it's too low, you might need a platelet transfusion to raise it.Your hemoglobin level should be 9 gm/dL or higher before the biopsy.Your kidney function, measured by a blood test, should be within a certain range before the biopsy.You must have finished standard treatments like surgery and radiation before joining the trial. If your tumor is unmethylated, you don't need to have had chemotherapy before joining. But if it's methylated, you must have had at least one chemotherapy treatment.Your liver function tests should show normal levels of total bilirubin, AST, and ALT. If you have Gilbert's Syndrome or suspected Gilbert's Syndrome, the total bilirubin level can be higher.Your blood clotting time (PT and aPTT) should be within a normal range before the biopsy. If you have a history of blood clots, you may be on blood thinners, but they will be managed around the time of the surgery. If you are on warfarin, your INR should be less than 2.0 before the biopsy.You had radiation therapy less than 12 weeks ago, unless your cancer has grown outside of the treated area, or you have had two scans at least 4 weeks apart showing that your cancer is getting worse, or have had confirmatory tissue biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: D2C7-IT
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.
Has the FDA sanctioned D2C7-IT for use?
"Our in-house assessment gave D2C7-IT a rating of 1, as this is an early stage study with limited evidence backing its safety and efficacy."
Answered by AI
Is recruitment for this experiment currently taking place?
"Clinicaltrials.gov shows that this research study is not currently recruiting participants, although it was initially publicized on May 5th 2015 and last amended on July 12th 2022. Nevertheless, there are sixteen-hundred forty-nine other trials actively looking for test subjects presently."
Answered by AI
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