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Topoisomerase I inhibitor
Pevonedistat + Chemotherapy for Solid Tumors and Lymphoma
Phase 1
Waitlist Available
Led By Jennifer H Foster
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bilirubin (sum of conjugated + unconjugated) =< upper limit of normal (ULN) for age
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as specified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying pevonedistat, irinotecan, and temozolomide to see how well they work in treating patients with solid tumors, central nervous system tumors, or lymphoma that have come back or do not respond to treatment.
Who is the study for?
This trial is for young patients (6 months to 21 years old) with recurrent or refractory solid tumors, CNS tumors, or lymphoma without curative therapy options. They must have measurable disease and be stable enough to participate. Prior treatment recovery and specific blood/organ function criteria are required. Pregnant individuals, those with severe health issues like uncontrolled high blood pressure, heart/lung diseases, liver impairment, bleeding disorders, or infections cannot join.Check my eligibility
What is being tested?
The study tests the combination of Pevonedistat with Irinotecan and Temozolomide in treating resistant cancers. It aims to find the safest doses while assessing how these drugs might better halt cancer growth compared to existing treatments by blocking enzymes that cancer cells need.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased infection risk; digestive issues like nausea and vomiting; fatigue; liver problems; hair loss from chemotherapy agents; and possible allergic reactions similar to other compounds in the drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bilirubin levels are within the normal range for my age.
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My kidney function is normal or near normal.
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My current cancer has no known cure or treatment to extend life with good quality.
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I am between 12 and 21 years old.
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My cancer has not spread to my bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Temozolomide
C Max of Pevonedistat in Combination With Irinotecan and Temozolomide
Clearance of Pevonedistat in Combination With Irinotecan and Temozolomide
+4 moreSecondary outcome measures
Anti-tumor Activity of Pevonedistat in Combination With Irinotecan and Temozolomide
Side effects data
From 2021 Phase 2 trial • 120 Patients • NCT0261077747%
Constipation
45%
Nausea
44%
Anaemia
40%
Fatigue
35%
Pyrexia
34%
Cough
34%
Neutropenia
27%
Diarrhoea
26%
Dyspnoea
24%
Febrile neutropenia
24%
Thrombocytopenia
21%
Decreased appetite
21%
Asthenia
21%
Vomiting
19%
Arthralgia
18%
Hypokalaemia
16%
Abdominal pain
15%
Oedema peripheral
15%
Dizziness
13%
Pneumonia
13%
Back pain
13%
Headache
13%
Pruritus
11%
Platelet count decreased
11%
Bronchitis
11%
Injection site pain
11%
Insomnia
11%
Chills
10%
Epistaxis
10%
Fall
10%
Neutrophil count decreased
10%
Oral herpes
10%
Oropharyngeal pain
10%
White blood cell count decreased
8%
Erythema
8%
Aspartate aminotransferase increased
8%
Hypomagnesaemia
8%
Muscular weakness
8%
Stomatitis
8%
Urinary tract infection
8%
Weight decreased
8%
Pleural effusion
6%
Dehydration
6%
Musculoskeletal pain
6%
Hypophosphataemia
6%
Contusion
6%
Pain in extremity
6%
Productive cough
6%
Non-cardiac chest pain Pain
6%
Sepsis
6%
Alanine aminotransferase increased
6%
Hypoalbuminaemia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Malaise
6%
Nasal congestion
6%
Non-cardiac chest pain
6%
Oral candidiasis
6%
Petechiae
6%
Nasopharyngitis
3%
Cellulitis
3%
Cerebrovascular accident
3%
Gastric haemorrhage
2%
Atrial fibrillation
2%
Congestive cardiomyopathy
2%
Acute febrile neutrophilic dermatosis
2%
Embolic stroke
2%
Endocarditis
2%
Failure to thrive
2%
Gastrointestinal necrosis
2%
Hepatic lesion
2%
Lower respiratory tract infection
2%
Lung infiltration
2%
Multiple organ dysfunction syndrome
2%
Myocardial infarction
2%
Wound infection
2%
Postoperative hypotension
2%
Acute myeloid leukaemia
2%
Ankle fracture
2%
Arthritis
2%
Arthritis reactive
2%
Autoimmune haemolytic anaemia
2%
Bacteraemia
2%
Bacterial sepsis
2%
Bronchopulmonary aspergillosis
2%
Cauda equina syndrome
2%
Cholecystitis
2%
Drug hypersensitivity
2%
Gastrointestinal ulcer perforation
2%
Haematuria
2%
Haemorrhage intracranial
2%
Hypoxia
2%
Influenza
2%
Inguinal hernia
2%
Ischaemic gastritis
2%
Leukopenia
2%
Myelodysplastic syndrome
2%
Myelodysplastic syndrome transformation
2%
Post procedural hypotension
2%
Rectal haemorrhage
2%
Renal colic
2%
Respiratory tract infection
2%
Soft tissue infection
2%
Spinal compression fracture
2%
Urinary tract infection enterococcal
2%
Urinary tract obstruction
2%
Lung infection
2%
Chronic kidney disease
2%
Death
2%
Gastritis erosive
2%
Supraventricular tachycardia
2%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pevonedistat, temozolomide, irinotecan)Experimental Treatment3 Interventions
Patients receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pevonedistat
2021
Completed Phase 2
~290
Irinotecan
2017
Completed Phase 4
~2680
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,670 Total Patients Enrolled
62 Trials studying Lymphoma
24,038 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,123 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,370 Patients Enrolled for Lymphoma
Jennifer H FosterPrincipal InvestigatorPediatric Early Phase Clinical Trial Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.I am not on any experimental treatments except for pevonedistat.My cancer can be measured or seen on tests.I have a recurring or resistant tumor with no standard treatment options left.I am not using highly effective birth control methods.I can do most daily activities by myself, and if I have a brain tumor, my condition has been stable for the last week.My bilirubin levels are within the normal range for my age.My kidney function is normal or near normal.My nervous system side effects from previous treatments are mild.I have severe liver problems or cirrhosis.I do not have a bleeding disorder that is currently uncontrolled.I am not on a stable or decreasing dose of corticosteroids.I have recovered from previous cancer treatments and meet the required waiting period.My oxygen level is above 94% without needing extra oxygen.My current cancer has no known cure or treatment to extend life with good quality.My seizures are well controlled with specific medication.I am between 12 and 21 years old.My cancer has not spread to my bone marrow.I haven't taken strong CYP3A4 inducers in the last 14 days.I have not taken seizure medication that affects enzymes in the last week.I do not have any infections that are currently uncontrolled.My child is between 6 and 12 months old and will join the study at a lower dose level.I have a known heart or lung condition.I have had a stem cell transplant, with or without full body radiation.My high blood pressure is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pevonedistat, temozolomide, irinotecan)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current regulatory standing of Pevonedistat?
"As this is only a Phase 1 trial, the safety of Pevonedistat has been deemed to be relatively low at level 1 on Power's scale. This limited data does not yet provide sufficient evidence for its efficacy and safety."
Answered by AI
What is the cohort size of this research initiative?
"This clinical trial has already met its recruitment goals and is no longer seeking participants. Initially posted on November 13th 2017, the last update was made October 20th 2022. Fortunately, there are still many other studies actively recruiting for lymphoma as well as Pevonedistat with a total of 4822 and 454 trials respectively."
Answered by AI
What criteria do applicants need to meet in order to become part of the trial?
"Qualified candidates for this clinical study should possess a confirmed diagnosis of lymphoma and be between 6 months old to 21 years. The trial is looking to recruit roughly 30 individuals in total."
Answered by AI
What maladies can be remedied by taking Pevonedistat?
"Pevonedistat is commonly utilised in the management of melanoma, but its use can also be extended to include treatment for soft tissue sarcoma (sts), primary central nervous system lymphoma (pcnsl) and other malignant neoplasms."
Answered by AI
How extensively is this research endeavor being conducted in North America?
"Participants for this medical trial can be enrolled from 20 different sites, including Children's Hospital of Pittsburgh of UPMC in Pittsburgh, Children's Hospital of Orange County in Orange and Washington University School of Medicine in Saint Louis."
Answered by AI
Are there any prior experiments that have utilized Pevonedistat in their research?
"Currently, there are 77 Pevonedistat-related studies in Phase 3 and a total of 454 live trials. The majority of these clinical investigations are based in Woolloongabba, Queensland but there is presence across 13272 other sites worldwide."
Answered by AI
Is this trial open to those aged 30 and over?
"To be eligible for this trial, patients must range between 6 months to 21 years old. There are 753 trials for participants under 18 and 4809 studies available for individuals over 65."
Answered by AI
Is recruitment still open for this experiment?
"According to the information on clinicaltrials.gov, this medical trial is not presently seeking participants. It was first published on November 13th 2017 and last updated October 20th 2022. Although it isn't recruiting patients at present, there are currently 5276 other trials accepting candidates."
Answered by AI
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