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Proteasome Inhibitor
Carfilzomib + Cyclophosphamide + Etoposide for Pediatric Cancer (POE14-01 Trial)
Phase 1
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment initiation through 30 days post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination of drugs to treat children with relapsed/refractory leukemia or solid tumors. The drugs are carfilzomib, cyclophosphamide, and etoposide. The trial will test if this combination is safe and what the maximum tolerated dose is.
Who is the study for?
Children aged 6 months to nearly 30 years with relapsed/refractory leukemia or solid tumors, who have recovered from previous treatments and have a life expectancy of at least 3 months. They must not be pregnant, breastfeeding, or have certain diseases like Fanconi Anemia or active infections.
What is being tested?
The trial is testing the effectiveness of carfilzomib combined with standard cancer drugs cyclophosphamide and etoposide in children whose cancer has returned or didn't respond to treatment. The goal is to find the safest dose that can manage these cancers.
What are the potential side effects?
Possible side effects include reactions related to infusion, blood disorders (like changes in blood cell counts), kidney and liver function issues, heart problems indicated by ECHO results, and potential for increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment initiation through 30 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment initiation through 30 days post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy.
Side effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Upper respiratory tract infection
49%
Platelet count decreased
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Insomnia
19%
Blood creatinine increased
18%
Pyrexia
17%
Hyperuricaemia
17%
Diarrhoea
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
16%
Blood lactate dehydrogenase increased
15%
Blood pressure increased
15%
Blood uric acid increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood glucose increased
14%
Blood bilirubin increased
14%
Constipation
12%
Neutrophil percentage increased
12%
Blood urea increased
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
11%
Hyponatraemia
10%
Neuropathy peripheral
10%
Bronchitis
10%
Blood potassium decreased
10%
Oedema peripheral
10%
Productive cough
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Influenza
8%
Hypoproteinaemia
8%
Blood albumin decreased
8%
Blood phosphorus increased
7%
Peripheral swelling
7%
Back pain
7%
Hypophosphataemia
7%
Mean cell volume increased
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Vomiting
7%
Abdominal distension
7%
Cataract
7%
Nasopharyngitis
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Hyperkalaemia
6%
Hypoglycaemia
6%
Hepatic function abnormal
6%
Respiratory tract infection
6%
Nausea
6%
Vision blurred
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Hypotension
1%
Obstructive airways disorder
1%
Interstitial lung disease
1%
Pleural effusion
1%
Deep vein thrombosis
1%
Chronic kidney disease
1%
Myelopathy
1%
Organising pneumonia
1%
Myolipoma
1%
Neuralgia
1%
Asthma
1%
Lipoma
1%
Cerebral ischaemia
1%
Nerve compression
1%
Disease progression
1%
Infusion site extravasation
1%
Escherichia sepsis
1%
Otitis media
1%
Periodontitis
1%
Pathological fracture
1%
Pain
1%
Device related infection
1%
Dysuria
1%
Soft tissue infection
1%
Spinal compression fracture
1%
Cardiac failure acute
1%
Supraventricular tachycardia
1%
Bronchiolitis
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CarfilzomibExperimental Treatment3 Interventions
Carfilzomib in combination with cyclophosphamide and etoposide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1430
Etoposide
2010
Completed Phase 3
~2960
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,442 Previous Clinical Trials
1,397,740 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,090 Total Patients Enrolled
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumUNKNOWN
2 Previous Clinical Trials
113 Total Patients Enrolled
Phoenix Children's HospitalLead Sponsor
76 Previous Clinical Trials
5,013,788 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a rare condition called Fanconi Anemia or another condition that affects your bone marrow's ability to function properly.You are of reproductive age and able to have children.You have Down syndrome.You are allergic to Captisol®, a substance used to dissolve carfilzomib.Patients must have one of the following conditions:You have received previous treatment for your condition.You have a serious health condition alongside the one being studied.You have received treatment with carfilzomib in the past.You have a type of cancer that has come back or is not responding to standard treatments. You do not have tumors in your brain or any other parts of your central nervous system. Having lymphoma is allowed. It is not necessary for you to have measurable disease.
Research Study Groups:
This trial has the following groups:- Group 1: Carfilzomib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.