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Monoclonal Antibodies

D2C7-IT + Atezolizumab for Glioma

Phase 1
Waitlist Available
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
Prior histopathology confirmed recurrent supratentorial WHO grade IV malignant glioma
Prothrombin and Partial Thromboplastin Times ≤ 1.2 x ULN prior to biopsy. Patients with prior history of thrombosis/embolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug in people with a certain type of brain tumor.

Who is the study for?
Adults with recurrent grade IV malignant glioma who have adequate organ function, are not pregnant or breastfeeding, and can undergo MRI. They must be able to sign informed consent, have a Karnofsky Performance Score of at least 70%, and meet specific blood count criteria. Excluded are those with immunodeficiency, severe lung or diabetes issues, certain allergies, recent immunotherapy or radiation unless showing progression, active infections or heart disease.Check my eligibility
What is being tested?
The trial is testing the combination of Atezolizumab (an immune checkpoint inhibitor) with two different concentrations of D2C7-IT (a monoclonal antibody targeting cancer cells) in patients with recurring brain tumors. It's a phase 1 study focusing on safety and how well these treatments work together.See study design
What are the potential side effects?
Potential side effects include allergic reactions to components in the drugs; increased risk for infection due to immune system suppression; possible worsening of autoimmune diseases; fatigue; liver enzyme changes; bleeding risks related to low platelet counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is a grade IV glioma that has come back.
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My blood clotting tests are normal and I can pause my blood thinner if needed for surgery.
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I am 18 years old or older.
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My platelet count is at least 100,000/µl without help, and over 125,000/µl for biopsy procedures.
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My kidney function, measured by creatinine, is within the normal range.
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I am able to care for myself but may not be able to do active work.
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My brain tumor has returned and is a grade IV.
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I am 18 years old or older.
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My brain tumor is a grade IV glioma that has come back.
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My recurrent tumor was confirmed by a biopsy before starting D2C7-IT treatment.
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My recurrent tumor was confirmed by a biopsy before getting D2C7-IT treatment.
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I cannot become pregnant or get someone pregnant.
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My brain tumor has come back and is a grade IV.
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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 an unacceptable adverse event

Trial Design

2Treatment groups
Experimental Treatment
Group I: D2C7-IT (6920 ng/mL) + AtezolizumabExperimental Treatment2 Interventions
Single D2C7-IT convection-enhanced delivery (CED) infusion (6920 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years
Group II: D2C7-IT (4613.2 ng/mL) + AtezolizumabExperimental Treatment2 Interventions
Single D2C7-IT convection-enhanced delivery (CED) infusion (4613.2 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years

Find a Location

Who is running the clinical trial?

Annick Desjardins, MDLead Sponsor
2 Previous Clinical Trials
73 Total Patients Enrolled
Istari Oncology, Inc.Industry Sponsor
12 Previous Clinical Trials
405 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,257 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04160494 — Phase 1
Malignant Glioma Research Study Groups: D2C7-IT (6920 ng/mL) + Atezolizumab, D2C7-IT (4613.2 ng/mL) + Atezolizumab
Malignant Glioma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04160494 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04160494 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration given their stamp of approval to D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)?

"Our team at Power assigned a score of 1 to the safety data concerning D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) as this is only in its first phase, with limited evidence affirming its efficacy and safety thus far."

Answered by AI

Has there ever been a similar study conducted prior to this one?

"To date, 350 ongoing studies utilizing D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) are being conducted across 1646 cities and 74 nations. The initial trial involving this drug began in 2008, sponsored by Hoffmann-La Roche with 720 enlisted participants who completed Phase 2 of the approval process. In the 13 years since then, 80 trials have been successfully concluded."

Answered by AI

What is the maximum capacity for participants in this experiment?

"Affirmative. The study, which was announced on the 20th of March 2020 and recently updated on 22nd of March 2022, is actively seeking patients to enrol in the trial across a single site. Clinicialtrials.gov confirms that 18 participants are needed for this project."

Answered by AI

Are there any unfilled slots in this clinical trial?

"The clinical trial is currently enrolling patients, as indicated on the information found on clinicaltrials.gov. This particular medical study was first advertised in March of 2020 and its details have been modified most recently in March of 2022."

Answered by AI

What conditions is D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) routinely utilized to treat?

"The experimental drug D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) is effective for treating small cell lung cancer, malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI
~3 spots leftby Dec 2024