Description:
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.
Title
- Brief Title: Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
20-08022610
- NCT ID:
NCT04994977
Conditions
- Atypical Choroid Plexus Papilloma
- Choroid Plexus Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Melphalan | | Intra-arterial Chemotherapy |
Carboplatin | | Intra-arterial Chemotherapy |
Topotecan | | Intra-arterial Chemotherapy |
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Intra-arterial Chemotherapy | Experimental | 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. | - Melphalan
- Carboplatin
- Topotecan
|
Eligibility Criteria
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:
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
- Subjects must have adequate cardiac function defined as:
- LVEF ≥ 50%
- QTc interval ≤ 450 msecs
- Subjects greater than 3 years of age must have a blood pressure that is ≤ 95th
percentile for age, height and gender at the time of enrollment.
- 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.
Exclusion Criteria:
- Females who are pregnant or lactating.
- 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 uncontrolled seizures.
- Subjects receiving enzyme inducing anticonvulsants.
- 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.
- This study will only enroll subjects with ACPP or CPC and will not enroll subjects
with choroid plexus papilloma (CPP). ACPP or CPC subjects diagnosed with hydrocephalus
or are presented with clinical symptoms of 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.
Maximum Eligible Age: | 100 Years |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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 |
Time Frame: | Through study completion, around 2 years for each subject |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | The number of successful angiography procedures, determined by examination of vasculature and assessment of catheter placement |
Time Frame: | On Day 1 of the trial for each subject |
Safety Issue: | |
Description: | |
Measure: | The number of patients with a tumor volume reduction response, determined by MRI assessments |
Time Frame: | Between 4-6 weeks after intra-arterial chemotherapy |
Safety Issue: | |
Description: | |
Measure: | The proportion of patients with a tumor volume reduction response, determined by MRI assessments |
Time Frame: | Between 4-6 weeks after intra-arterial chemotherapy |
Safety Issue: | |
Description: | |
Measure: | The number of patients with a tumor vascularity reduction response, determined by MRI assessments |
Time Frame: | Between 4-6 weeks after intra-arterial chemotherapy |
Safety Issue: | |
Description: | |
Measure: | The proportion of patients with a tumor vascularity reduction response, determined by MRI assessments |
Time Frame: | Between 4-6 weeks after intra-arterial chemotherapy |
Safety Issue: | |
Description: | |
Measure: | The success of second look surgery determined by measuring the extent of tumor resection |
Time Frame: | Around 7 weeks after intra-arterial chemotherapy, during second look surgery |
Safety Issue: | |
Description: | |
Measure: | The success of second look surgery determined by amount of blood loss |
Time Frame: | Around 7 weeks after intra-arterial chemotherapy, during second look surgery |
Safety Issue: | |
Description: | |
Measure: | The success of second look surgery determined by percent of blood loss |
Time Frame: | Around 7 weeks after intra-arterial chemotherapy, during second look surgery |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Weill Medical College of Cornell University |
Last Updated
August 6, 2021