← Back to Search

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
Patients must have either of the following:
- Relapsed/refractory non-CNS solid tumor that has not responded or has relapsed and for which no standard treatment is available. Patients may not have primary CNS tumors or CNS metastases. Lymphoma patients are permitted. Patients do not need to have measurable disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post treatment initiation
Awards & highlights

POE14-01 Trial 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.Check my eligibility
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.See study design
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.

POE14-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Patients must have one of the following conditions:
Select...
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.
Select...
You have received previous treatment for your condition.
Select...
You are of reproductive age and able to have children.

POE14-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors
Secondary outcome measures
Determine patient response rate (CR, PR, SD, PD) with this regimen
To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity
To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy.
+5 more

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234
62%
Anaemia
49%
Platelet count decreased
49%
Upper respiratory tract infection
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Diarrhoea
17%
Hyperuricaemia
16%
Blood lactate dehydrogenase increased
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Hypoalbuminaemia
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
14%
Hyperglycaemia
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Hyponatraemia
11%
Alanine aminotransferase increased
11%
Hypercalcaemia
10%
Blood potassium decreased
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Bronchitis
10%
Aspartate aminotransferase increased
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood albumin decreased
8%
Blood phosphorus increased
8%
Hypoproteinaemia
8%
Influenza
7%
Prealbumin decreased
7%
Peripheral swelling
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Nasopharyngitis
7%
Bilirubin conjugated increased
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Thrombocytopenia
6%
Vision blurred
6%
Nausea
6%
Hepatic function abnormal
6%
Respiratory tract infection
6%
Hyperkalaemia
6%
Hypoglycaemia
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Bone pain
2%
Localised infection
2%
Cardiac amyloidosis
1%
Dysuria
1%
Pathological fracture
1%
Chronic kidney disease
1%
Deep vein thrombosis
1%
Hypotension
1%
Cardiac failure acute
1%
Spinal compression fracture
1%
Lipoma
1%
Periodontitis
1%
Asthma
1%
Nerve compression
1%
Otitis media
1%
Myelopathy
1%
Soft tissue infection
1%
Cerebral ischaemia
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Pleural effusion
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
1%
Pain
1%
Bronchiolitis
1%
Device related infection
1%
Pancreatitis acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone

POE14-01 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
~1440
Etoposide
2010
Completed Phase 3
~2440
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,377 Previous Clinical Trials
17,333,095 Total Patients Enrolled
40 Trials studying Leukemia
11,918 Patients Enrolled for Leukemia
Pediatric Oncology Experimental Therapeutics Investigators' ConsortiumUNKNOWN
2 Previous Clinical Trials
113 Total Patients Enrolled
1 Trials studying Leukemia
90 Patients Enrolled for Leukemia
AmgenIndustry Sponsor
1,359 Previous Clinical Trials
1,384,507 Total Patients Enrolled
53 Trials studying Leukemia
13,814 Patients Enrolled for Leukemia

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02512926 — Phase 1
Leukemia Research Study Groups: Carfilzomib
Leukemia Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT02512926 — Phase 1
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02512926 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any US-based healthcare centers conducting research on this topic?

"Currently, this clinical trial is enrolling out of 7 different sites located in San Antonio, Phoenix and Hershey as well as four other cities. To reduce the amount of time spent travelling to a medical centre for participation, it may be best to choose the one closest to you."

Answered by AI

Is enrollment currently open for this clinical experiment?

"Per clinicaltrials.gov, this investigation is still recruiting patients and has been since February 16th 2016. The trial's data was most recently updated on April 12th 2022."

Answered by AI

Is it possible for me to participate in this clinical experiment?

"For this clinical trial, 50 patients between 6 months and 29 years of age with leukemia or other non-CNS solid tumors are being recruited. Candidates must have relapsed/refractory diseases that haven't responded to standard treatments, an estimated life expectancy of at least 3 months, a Lansky or Karnofsky score higher than 50%, and be recovered from any prior chemotherapy. Additionally, it is necessary that 14 days have elapsed since the administration of myelosuppressive therapy or biologic agents such as monoclonal antibodies and radiation therapies; 90 days if substantial bone marrow radiation has been administered."

Answered by AI

Is participation for individuals aged 25 or older permissible in this experiment?

"Based on the outlined requirements, this trial has a lower age limit of 6 months and an upper boundary at 29 years old."

Answered by AI

Can you elaborate on the additional investigations involving Carfilzomib?

"Presently, 1065 Carfilzomib studies are operational; with 217 in their final stages. Philadelphia, Pennsylvania has the highest concentration of trials for this medication but it is being researched at 38682 different facilities worldwide."

Answered by AI

Could you explain the risks associated with Carfilzomib use?

"Based on the limited amount of data available, Carfilzomib has been assigned a score of 1 for safety. This is because it is currently in Phase 1 trials and there are few studies to corroborate its efficacy or security protocols."

Answered by AI

What is the scale of participation for this clinical experiment?

"This clinical trial necessitates the recruitment of 50 appropriate participants. For this endeavor, Amgen is partnering with University of Texas Health Science Center at San Antonio and Phoenix Children's Hospital to carry out their research."

Answered by AI

To what conditions does Carfilzomib offer therapeutic relief?

"Carfilzomib is usually used for the treatment of leukemia, but it can also be applied to address prostate cancer, lung cancers and small cell ell lung cancer (sclc)."

Answered by AI
~0 spots leftby Mar 2025