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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a little over a year for each subject
Awards & highlights

Study Summary

This trial will test if a new chemotherapy method is safe and effective for people with a certain type of brain tumor. If it is, it may help shrink the tumor before surgery.

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.Check my eligibility
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.See study design
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.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a little over a year for each subject
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a little over a year for each subject for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of intra-arterial chemotherapy in subjects with ACPP and CPC, measured by the number of serious adverse events that are reported as at least possible related to the intervention that occur in subjects on the trial
Secondary outcome measures
The number of patients with a tumor vascularity reduction response, determined by MRI assessments
The number of patients with a tumor volume reduction response, determined by MRI assessments
The number of successful angiography procedures, determined by examination of vasculature and assessment of catheter placement
+5 more
Other outcome measures
Extent of pathology correlation to tumor vascularity and tumor viability

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
~6670
Topotecan
2017
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,289 Total Patients Enrolled
Mark Souweidane, M.D.Principal InvestigatorWeill Medical College of Cornell University

Media Library

Carboplatin (Platinum-based compound) Clinical Trial Eligibility Overview. Trial Name: NCT04994977 — Phase 1
Choroid Plexus Papilloma Research Study Groups: Intra-arterial Chemotherapy
Choroid Plexus Papilloma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04994977 — Phase 1
Carboplatin (Platinum-based compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04994977 — Phase 1

Frequently Asked Questions

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

Has Melphalan been authenticated by the FDA?

"Our team at Power rated Melphalan a 1 due to its Phase 1 classification; this indicates that only sparse data exists regarding the drug's safety and efficacy."

Answered by AI

Are participants still being accepted for this medical study?

"Correct. Information on the clinicaltrials.gov platform reveals that this experiment is actively recruiting applicants and was initially posted on November 1, 2022 with its most recent edit occurring 11/11/2022. The study requires 6 participants from a single site to complete it successfully."

Answered by AI

Does this study accept participants in their golden years?

"Recruitment is open to individuals aged 0-100 years old."

Answered by AI

What medical conditions is Melphalan commonly prescribed for?

"Melphalan is prescribed to treat advanced thymoma quite often. Furthermore, it has also been used with some success in treating testicular cancer, carcinoma, neuroendocrine disorders and other severe medical conditions."

Answered by AI

How many participants have contributed to the experiment thus far?

"Affirmative. According to clinicaltrials.gov, this research initiative is currently recruiting participants. It was initially made available on November 1st 2022 and the information has been most recently updated 11/11/2022. Six individuals are needed at a single medical facility for the study."

Answered by AI

What criteria must a person meet in order to be eligible for this trial?

"This medical trial is looking to recruit 6 participants aged 0-100 who have been diagnosed with carcinoma. The selection process requires that the patient must not have received platelet transfusions in the last 7 days and pass other criteria such as a Karnofsky or Lansky Performance Score ≥ 60%, Absolute neutrophil count ≥ 1,000/μL, Platelets ≥ 100,000/μL, Hemoglobin ≥ 8 g/dL (transfusion independent), Total bilirubin < 1.5 times upper limit of normal for age, AST (SGOT)/ALT(SGPT) < 2.5 X institutional"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery
2023. "Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04994977.
~4 spots leftby Dec 2025
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