What side effects are associated with this type of intervention?

Common treatments for brain tumors, particularly targeted therapies and chemotherapeutic agents designed to cross the blood-brain barrier, include drugs like temozolomide, carboplatin, and newer agents like ONC201. Known side effects of these treatments can include nausea, vomiting, fatigue, and myelosuppression (decreased production of blood cells). Specific targeted therapies may also cause unique side effects such as liver toxicity, diarrhea, and skin rashes. Additionally, treatments that penetrate the CNS can sometimes lead to neurotoxicity, manifesting as headaches, cognitive changes, or seizures.

What prior FDA approvals exist?

Several FDA-approved treatments for brain tumors and metastases include targeted therapies and chemotherapeutic agents designed to cross the blood-brain barrier. For instance, temozolomide is a well-known chemotherapeutic agent used for glioblastoma that can penetrate the CNS. Additionally, investigational therapies like ONC201, which targets mitochondrial metabolism and the stress response pathway, are being studied for their efficacy in treating H3 K27M-mutant gliomas. These treatments aim to improve drug delivery to the brain and enhance therapeutic outcomes for patients with brain tumors.

What other types of research exist?

<ol> <li>GA-17-NCS: An immunoconjugate composed of a monoclonal antibody (GA-17) linked to neocarzinostatin, which has shown significant suppression of glioma growth in preclinical studies by targeting tyrosine-specific phosphorylated antigens on astrocytomas.</li> <li></li> </ol> DX1: An anti-DNA autoantibody that crosses the BBB via ENT2 transporters and has demonstrated efficacy in suppressing glioblastoma and breast cancer brain metastases. 3. Tf-CRM107: A transferrin receptor-targeted toxin conjugate that has shown potent cytotoxicity against cells expressing the transferrin receptor and has demonstrated promising results in phase I clinical trials for malignant gliomas.

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QBS72S for Brain Cancer from Breast Cancer

Phase 2

Recruiting

Led By Melanie H Gephart, MD, MAS

Research Sponsored by Melanie Hayden Gephart

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 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called QBS72S for people with advanced breast cancer that has spread to the brain. The goal is to see if this drug can shrink brain tumors and help patients live longer. Researchers are also checking if the drug is safe for these patients.

Who is the study for?

Adults with advanced breast cancer that has spread to the brain, who've had prior chemotherapy. They must be able to consent, follow study procedures, and have good organ function and performance status. Contraception is required for those who can conceive. Exclusions include recent major surgery, certain medical conditions or treatments, high steroid doses, severe drug allergies, other active cancers within 3 years (except some skin cancers), pregnancy/breastfeeding.

What is being tested?

The trial tests QBS72S's effectiveness and safety in treating brain metastases from breast cancer. Participants will receive this investigational drug after completing previous treatments including chemo and radiotherapy as per specified waiting periods.

What are the potential side effects?

While specific side effects of QBS72S are not listed here, similar drugs may cause allergic reactions or issues related to the components like sulfobutylether-β-cyclodextrin or nitrogen mustard chemotherapeutics which could lead to various organ-related side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response against Intracranial Tumor Lesions, Cohort 1 (Stages 1+2)

RECIST 1.1 response criteria

Secondary study objectives

Duration of Response (DoR), Cohort 1 (Stages 1+2)

Overall Survival (OS), Cohort 1 (Stages 1+2)

Progression-free Survival (PFS), Cohort 1 (Stages 1+2)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)Experimental Treatment1 Intervention

All participants in Cohort 3 will receive QBS72S IV injections once monthly until disease progression.

Group II: Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1)Experimental Treatment1 Intervention

All participants in Cohort 1 will receive QBS72S IV injections once monthly until disease progression.

Group III: Patients with Breast Cancer Leptomeningeal Disease (Cohort 2)Experimental Treatment1 Intervention

All participants in Cohort 2 will receive QBS72S IV injections once monthly until disease progression.

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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

Common treatments for brain tumors, such as targeted therapies and chemotherapeutic agents, are designed to cross the blood-brain barrier and act on cancer cells within the central nervous system. Targeted therapies work by interfering with specific molecular pathways involved in tumor growth and progression, such as inhibiting growth factor receptors or signaling proteins. Chemotherapeutic agents, on the other hand, aim to kill rapidly dividing cancer cells by damaging their DNA or disrupting their cellular machinery. These mechanisms are vital for brain tumor patients as they offer a means to effectively reach and treat tumors within the brain, potentially improving outcomes and survival rates.

Bioinformatics analysis reveals potential candidate drugs for different subtypes of glioma.The combination of novel targeted molecular agents and radiation in the treatment of pediatric gliomas.