Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery

Study Purpose

This study will test the safety and efficacy of intra-arterial chemotherapy in subjects with newly diagnosed, residual, or recurrent atypical choroid plexus papilloma and choroid plexus carcinoma prior to a second surgery. It is believed that intra-arterial chemotherapy will be safe and feasible for this population and will result in decreased tumor size, which may further improve the goals of a second-look surgery.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 0 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04994977
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mark Souweidane, M.D.
Principal Investigator Affiliation Weill Medical College of Cornell University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atypical Choroid Plexus Papilloma, Choroid Plexus Carcinoma
Additional Details

The intent of this study is to determine if intra-arterial chemotherapy is a safe and effective option for subjects with atypical choroid plexus papilloma and choroid plexus carcinoma prior to receiving second-look surgery. Angiography occurs when a catheter is inserted through the subjects vasculature to the major vessels that supply cerebral circulation. Subjects on this trial will undergo a a cerebral angiogram to determine the ideal arteries to use for drug infusion. Once identified, chemotherapy will be delivered through the catheter directly to the site of tumor.

Arms & Interventions

Arms

Experimental: Intra-arterial Chemotherapy

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.

Interventions

Drug: - Melphalan

Given at 0.5 mg/ml.

Drug: - Carboplatin

Given at 5 mg/ml.

Drug: - Topotecan

Given at 0.2 mg/ml.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10025

Site Contact

Mark Souweidane, M.D.

[email protected]

212-746-2363

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