Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus P… (NCT04994977) | Clinical Trial Compass
TerminatedPhase 1
Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery
Stopped: Study terminated due to low accrual
United States1 participantsStarted 2023-05-04
Plain-language 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.
Who can participate
Age range0 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. 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
Exclusion criteria
✕
What they're measuring
1
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
Timeframe: Through study completion, a little over a year for each subject
Trial details
NCT IDNCT04994977
SponsorWeill Medical College of Cornell University
✕. 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.
✕. Subjects who are receiving any other anticancer or investigational agents.
✕. 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.
✕. 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.
✕. 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.