What is the mechanism of action of this treatment?

D2C7-IT immunotoxin targets specific antigens on glioma cells, binding to them and delivering a toxic payload that kills the tumor cells. This targeted approach is crucial for brain cancer patients as it minimizes damage to healthy brain tissue. Other treatments include chemotherapy, which kills rapidly dividing cells, and radiation therapy, which uses high-energy particles to destroy cancer cells. Targeted therapies and immunotherapies offer the potential for more effective and less harmful treatment options.

What side effects are associated with this type of intervention?

Common treatments for brain cancer, such as D2C7-IT, which involves targeted delivery of toxic agents to tumor cells, can have several side effects. These may include local inflammation, edema, and necrosis at the treatment site. Systemic side effects can include immunosuppression, leading to increased risk of infections, and general toxicity symptoms such as fatigue, nausea, and vomiting. Additionally, treatments like chemotherapy and radiation can cause myelosuppression, leading to anemia, thrombocytopenia, and leukopenia, which further increase the risk of infections and bleeding. Patients may also experience neurological side effects, including cognitive changes and neuropathy.

What prior FDA approvals exist?

The FDA has approved several treatments for brain cancer, including targeted therapies and immunotherapies. One notable example is bevacizumab (Avastin), which targets vascular endothelial growth factor (VEGF) to inhibit tumor blood vessel growth. Another example is temozolomide, an oral chemotherapy drug that is often used in combination with radiation therapy for glioblastoma. While specific immunotoxins like D2C7-IT are still under investigation, these approved treatments highlight the ongoing efforts to target and disrupt tumor growth through various mechanisms.

What other types of research exist?

Promising novel alternatives to D2C7-IT for brain cancer patients include: 1) Small molecule inhibitors of mutant IDH1 and IDH2, such as Ivosidenib and Vorasidenib, which are in clinical trials for IDH-mutant gliomas. 2) BRAF/MEK inhibitors like Dabrafenib and Trametinib, which have shown efficacy in BRAF V600E-mutant gliomas. 3) Chimeric Antigen Receptor (CAR) T-cell therapies targeting specific antigens on tumor cells. These alternatives are in various stages of clinical development and have shown potential in improving outcomes for brain cancer patients.

← Back to Search

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

No Placebo-Only Group

Summary

This trial is testing a new medicine called D2C7-IT for patients with aggressive brain tumors that have returned. The medicine is delivered directly into the tumor to ensure it spreads evenly and targets cancer cells. The goal is to find the safest and most effective dose for future studies.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) and/or recommended phase II dose of D2C7-IT

Secondary study objectives

Association between EGFRvIII and EGFRwt expression and PFS and OS.

Overall survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

D2C7-IT immunotoxin targets specific antigens on glioma cells, binding to them and delivering a toxic payload that kills the tumor cells. This targeted approach is crucial for brain cancer patients as it minimizes damage to healthy brain tissue. Other treatments include chemotherapy, which kills rapidly dividing cells, and radiation therapy, which uses high-energy particles to destroy cancer cells. Targeted therapies and immunotherapies offer the potential for more effective and less harmful treatment options.