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Experimental Artery-Directed chemo for rare brain tumors: tiny trial ends early

NCT ID NCT04994977

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested giving chemotherapy drugs directly into the brain's arteries to treat two rare types of choroid plexus tumors. The goal was to shrink the tumor before a second surgery. Only 1 person was enrolled, and the study was terminated, so we have very little information about safety or effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melphalan, carboplatin, and topotecan (chemotherapy drugs given directly into an artery)
What this could lead to
If it works, this approach could shrink these rare brain tumors before surgery, making the operation safer and more effective.
What could go wrong
This was a very early Phase 1 trial with only 1 participant, so we don't know if it's safe or effective. The study was terminated, meaning results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

1 person

The number who actually took part.

Started

May 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects with a histologically confirmed diagnosis of ACPP or CPC that is newly diagnosed, residual or recurrent. 2. Subjects must have a Karnofsky or Lansky Performance Score ≥ 60 % assessed within two weeks prior to enrollment. Karnofsky is used for patients ≥ 16 years and Lansky for those \< 16. 3. Subjects must have normal organ and marrow function documented within 14 days of enrollment and within 7 days of the start of treatment as noted below: 1. Absolute neutrophil count ≥ 1,000/μL 2. Platelets ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment) 3. Hemoglobin ≥ 8 g/dL (may receive PRBC transfusions) 4. Total bilirubin \< 1.5 times upper limit of normal for age 5. AST (SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal for age 6. Creatinine clearance or radioisotope GFR ≥ 70 ml/min/1.73m2 or a serum creatinine WNL for age as determined using the Schwartz formula.36 7. Sodium, Potassium, Calcium and Magnesium \< 1.5x institutional ULN 8. Albumin ≥ 3 g/dL 4. Subjects who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment. 5. Subjects with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment. 6. If the subject has any of the following therapies, must be at least: * 4 weeks post-focal RT (radiation therapy), 3 months post-CSI (craniospinal irradiation) * 4 weeks post-myelosuppressive chemotherapy (if post-nitrosoureas, must have 6 weeks therapy) * 4 weeks post-monoclonal antibodies * 1 week post-targeted therapy 7. If subject has received any previous treatment, all treatment related toxicities should have recovered to \< grade 2 8. Subject or parent must sign a written informed consent document according to institutional guidelines. Exclusion Criteria: 1. Females who are pregnant or lactating. 2. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) likely to interfere with the study procedures or results. 3. Subjects who are receiving any other anticancer or investigational agents. 4. Subjects with uncontrolled seizures. 5. Subjects receiving enzyme inducing anticonvulsants. 6. Subjects with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above. 7. Subjects who have had an allogenic bone marrow transplant \< 6 months prior to enrollment or an autologous bone marrow/stem cell transplant \< 3 months prior to enrollment. 8. Subjects with multifocal disease or disease that has been disseminated will not be eligible for this study. They will undergo systemic chemotherapy and their disease will be further evaluated prior to be eligible for 2nd look surgery. 9. This study will only enroll subjects with ACPP or CPC and will not enroll subjects with choroid plexus papilloma (CPP). ACPP or CPC subjects with symptomatic hydrocephalus will not be eligible for this study. These subjects will have to be treated for their hydrocephalus and be re-evaluated according to our eligibility criteria in order to be enrolled.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Weill Cornell Medicine

    New York, New York, 10025, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.