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

Who is this study for? Patients with newly diagnosed, residual, or recurrent atypical choroid plexus papilloma and choroid plexus carcinoma
What treatments are being studied? Melphalan+Carboplatin+Topotecan
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 100
Healthy Volunteers: f
View:

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

• 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.

• 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:

∙ Absolute neutrophil count ≥ 1,000/μL

‣ Platelets ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)

‣ Hemoglobin ≥ 8 g/dL (may receive PRBC transfusions)

‣ Total bilirubin \< 1.5 times upper limit of normal for age

‣ AST (SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal for age

‣ Creatinine clearance or radioisotope GFR ≥ 70 ml/min/1.73m2 or a serum creatinine WNL for age as determined using the Schwartz formula.36

‣ Sodium, Potassium, Calcium and Magnesium \< 1.5x institutional ULN

‣ Albumin ≥ 3 g/dL

• Subjects who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment.

• Subjects with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.

• 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

• If subject has received any previous treatment, all treatment related toxicities should have recovered to \< grade 2

• Subject or parent must sign a written informed consent document according to institutional guidelines.

Locations
United States
New York
Weill Cornell Medicine
New York
Time Frame
Start Date: 2023-05-04
Completion Date: 2026-12
Participants
Target number of participants: 1
Treatments
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.
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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