What side effects are associated with this type of intervention?

Intra-arterial chemotherapy for Choroid Plexus Papilloma aims to maximize local drug concentration while minimizing systemic exposure. Common side effects include neurotoxicity, which can present as cognitive changes, motor deficits, or seizures, and vascular complications such as stroke or hemorrhage. Systemic side effects, though reduced, may still occur and include nausea, vomiting, and myelosuppression.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for intra-arterial chemotherapy for Choroid Plexus Papilloma. However, intra-arterial chemotherapy is a method being studied for its potential to deliver high concentrations of chemotherapeutic agents directly to the tumor site, thereby reducing systemic exposure. This approach is being explored in clinical trials for various brain tumors, including Choroid Plexus Papilloma, to improve the efficacy and safety of chemotherapy. Broadly, chemotherapeutic agents like carboplatin and etoposide have been used in similar contexts for other types of brain tumors.

What other types of research exist?

Promising novel alternatives to intra-arterial chemotherapy for Choroid Plexus Papilloma patients include targeted therapies and immunotherapies. Targeted therapies such as MEK inhibitors (e.g., selumetinib) and BRAF inhibitors (e.g., vemurafenib) have shown efficacy in treating other brain tumors with specific genetic mutations. Immunotherapies, including checkpoint inhibitors (e.g., pembrolizumab) and CAR-T cell therapy, are also being explored for their potential to target tumor cells more precisely. Additionally, advancements in localized drug delivery systems, such as convection-enhanced delivery (CED), are being investigated to improve the precision and efficacy of chemotherapeutic agents directly to the tumor site.

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Platinum-based compound

Chemotherapy for Choroid Plexus Cancer

Phase 1

Recruiting

Led By Mark Souweidane, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with a histologically confirmed diagnosis of ACPP or CPC that is newly diagnosed, residual or recurrent

Subjects must have normal organ and marrow function documented within specific parameters

Must not have

Females who are pregnant or lactating

Subjects who are receiving any other anticancer or investigational agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up around 7 weeks after intra-arterial chemotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if delivering cancer drugs directly to brain tumors through blood vessels is safe and effective for patients with specific types of brain tumors. The goal is to shrink the tumors.

Who is the study for?

This trial is for individuals with a specific type of brain tumor, either newly diagnosed, remaining after treatment, or returned. They must be relatively active (able to care for themselves), have normal body functions as tested recently, and not be on increasing doses of steroids. Pregnant women and those with serious unrelated illnesses or taking certain other drugs are excluded.

What is being tested?

The study tests intra-arterial chemotherapy using Melphalan, Carboplatin, and Topotecan in patients before they undergo a second surgery. The goal is to see if this approach safely shrinks the tumors and improves surgical outcomes.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, decreased blood cell counts leading to increased infection risk or bleeding problems, nausea or vomiting from the chemo drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is ACPP or CPC, whether it's new, remaining, or has come back.

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My organ and bone marrow functions are normal.

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I have been on a stable or decreasing dose of dexamethasone for at least one week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I am not currently taking any cancer treatment or experimental drugs.

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I have seizures that are not controlled by medication.

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I recently had a bone marrow transplant.

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I have a brain tumor called CPP or I have water on the brain causing symptoms.

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My cancer has spread to multiple locations.

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I am taking medication for seizures that affects how other drugs work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ around 7 weeks after intra-arterial chemotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~around 7 weeks after intra-arterial chemotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and around 7 weeks after intra-arterial chemotherapy for reporting.

Treatment Details

Study Objectives

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

Other study objectives

Extent of pathology correlation to tumor vascularity and tumor viability

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: Intra-arterial ChemotherapyExperimental Treatment3 Interventions

Subjects are pre-treated with heparin, and then given single doses of Melphalan, Carboplatin, and Topotecan consecutively via intra-arterial infusion. Multiple arteries may be used, with the total dose of the drugs remaining the same.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

Carboplatin

2014

Completed Phase 3

~6120

Topotecan

2017

Completed Phase 3

~2460

0 / 10Eligibility criteria met

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

Intra-arterial chemotherapy for Choroid Plexus Papilloma involves the direct delivery of chemotherapeutic agents to the tumor site via arteries. This approach maximizes the local concentration of the drug at the tumor, enhancing its efficacy in reducing tumor size while minimizing systemic exposure and associated side effects. This is particularly beneficial for CPP patients as it can improve the outcomes of subsequent surgeries and reduce the risk of adverse effects, thereby maintaining the overall health and quality of life of the patients.

Treatment of adult brainstem glioma with combined antiangiogenic therapy: a case report and literature review.