Study Summary
This trial is studying two chemotherapy regimens to treat patients with Wilms tumor.
Eligible Conditions
- Anaplastic Wilms Tumor
- Stage II Kidney Wilms Tumor
- Stage III Kidney Wilms Tumor
- Stage IV Kidney Wilms Tumor
- Wilms Tumor
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: From study entry to death due to any cause, assessed up to 5 years after study enrollment
Year 5
p53 biomarker analysis
Year 5
Overall survival (OS)
Year 5
OS for patients with gross total disease resection
Year 5
EFS for patients with gross total disease resection
Event-free survival (EFS)
Year 5
Association of the number of nodes examined with EFS and OS
Week 30
Incidence of grade 3-5 renal toxicity
Week 42
Collection of blood and urine samples
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
36%Febrile neutropenia
31%Death NOS
30%Diarrhea
22%Pain
21%Hyperglycemia
16%Alanine aminotransferase increased
16%Anorexia
16%Infections and infestations - Other, specify
14%Hypokalemia
13%Nausea
11%Hyponatremia
10%Weight loss
9%Aspartate aminotransferase increased
9%Constipation
9%Dehydration
9%Hypophosphatemia
9%Vomiting
9%Mucositis oral
9%Anemia
8%Platelet count decreased
8%Sepsis
7%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%Abdominal pain
7%Colitis
7%Catheter related infection
6%Hypoalbuminemia
6%Hypotension
6%GGT increased
6%Hypocalcemia
6%Fever
6%Urinary retention
6%White blood cell decreased
5%Urinary tract infection
5%Typhlitis
5%Anxiety
5%Neutrophil count decreased
4%Epistaxis
4%Enterocolitis
4%Lipase increased
4%Pleural effusion
4%Urinary tract obstruction
4%Peripheral motor neuropathy
4%Skin infection
4%Serum amylase increased
3%Syncope
3%Dermatitis radiation
3%Bone pain
3%Dyspnea
3%Lymphocyte count decreased
3%Wound infection
3%Hematuria
3%Blood bilirubin increased
3%Edema limbs
3%Hypertension
3%Hypercalcemia
3%Sinus tachycardia
2%Abdominal distension
2%Creatinine increased
2%Tumor pain
2%Lung infection
2%Acute kidney injury
2%Apnea
2%Left ventricular systolic dysfunction
2%Pancreatitis
2%Peripheral sensory neuropathy
2%Rectal hemorrhage
2%Thromboembolic event
2%Stridor
2%Back pain
2%Enterocolitis infectious
2%Hyperkalemia
2%Musculoskeletal and connective tissue disorder - Other, specify
2%Investigations - Other, specify
2%Muscle weakness lower limb
2%Proctitis
2%Pain in extremity
2%Urticaria
2%Depressed level of consciousness
2%Vulval infection
2%Allergic reaction
2%Portal hypertension
2%Upper gastrointestinal hemorrhage
2%Stoma site infection
2%Skin ulceration
1%Oral pain
1%Anaphylaxis
1%Ascites
1%Hypoxia
1%Confusion
1%Multi-organ failure
1%Alkaline phosphatase increased
1%Anal ulcer
1%Ejection fraction decreased
1%Fracture
1%Heart failure
1%Esophageal pain
1%Gastric hemorrhage
1%Gum infection
1%Hepatobiliary disorders - Other, specify
1%Hydrocephalus
1%Ileus
1%Oral hemorrhage
1%Rectal fistula
1%Pulmonary edema
1%Penile pain
1%Sore throat
1%Tracheitis
1%Acidosis
1%Vascular disorders - Other, specify
1%Vasovagal reaction
1%Abdominal infection
1%Anal hemorrhage
1%Bladder spasm
1%Anal mucositis
1%Congenital, familial and genetic disorders - Other, specify
1%Chest wall pain
1%Device related infection
1%Hoarseness
1%CPK increased
1%Depression
1%Gastrointestinal disorders - Other, specify
1%Esophagitis
1%Gastric ulcer
1%Laryngeal mucositis
1%Hypoglycemia
1%Myositis
1%Menorrhagia
1%Nail infection
1%Renal and urinary disorders - Other, specify
1%Pharyngitis
1%Pneumonitis
1%Spinal fracture
1%Seizure
1%Small intestine infection
1%Gait disturbance
1%Encephalopathy
1%Generalized muscle weakness
1%Pelvic pain
1%Laryngeal edema
1%Rectal pain
1%Disseminated intravascular coagulation
1%Endocrine disorders - Other, specify
1%Respiratory, thoracic and mediastinal disorders - Other, specify
1%Pleuritic pain
1%Sinusitis
1%Bone marrow hypocellular
1%Appendicitis
1%Esophageal infection
1%Delirium
1%Ear and labyrinth disorders - Other, specify
1%Esophageal stenosis
1%Hypertriglyceridemia
1%INR increased
1%Myelodysplastic syndrome
1%Rash maculo-papular
1%Respiratory failure
1%Anal fistula
1%Lethargy
1%Fall
1%Dizziness
1%Eye disorders - Other, specify
1%Tooth infection
1%Fatigue
1%Headache
1%Skin and subcutaneous tissue disorders - Other, specify
1%Hypernatremia
1%Insomnia
1%Kyphosis
1%Soft tissue infection
1%Hypomagnesemia
1%Irregular menstruation
1%Irritability
1%Joint range of motion decreased cervical spine
1%Pyramidal tract syndrome
1%Pain of skin
1%Pneumothorax
1%Postoperative hemorrhage
1%Pruritus
1%Salivary duct inflammation
1%Tumor lysis syndrome
1%Upper respiratory infection
Trial Design
2 Treatment Groups
Arm II (Regimen ICE/Cyclo/Topo)
1 of 2
Arm I (Regimen UH-3)
1 of 2
Experimental Treatment
221 Total Participants · 2 Treatment Groups
Primary Treatment: Ifosfamide · No Placebo Group · Phase 2
Arm II (Regimen ICE/Cyclo/Topo)Experimental Group · 15 Interventions: Positron Emission Tomography, Surgical Procedure, Radiation Therapy, Transabdominal Ultrasound, Biopsy, Biospecimen Collection, Topotecan, Bone Scan, Computed Tomography, Cyclophosphamide, Etoposide, Magnetic Resonance Imaging, X-Ray Imaging, Carboplatin, Ifosfamide · Intervention Types: Procedure, Procedure, Radiation, Procedure, Procedure, Procedure, Drug, Procedure, Procedure, Drug, Drug, Procedure, Procedure, Drug, Drug
Arm I (Regimen UH-3)Experimental Group · 15 Interventions: Positron Emission Tomography, Radiation Therapy, Transabdominal Ultrasound, Biopsy, Biospecimen Collection, Bone Scan, Computed Tomography, Cyclophosphamide, Etoposide, Magnetic Resonance Imaging, Vincristine, X-Ray Imaging, Irinotecan, Carboplatin, Doxorubicin · Intervention Types: Procedure, Radiation, Procedure, Procedure, Procedure, Procedure, Procedure, Drug, Drug, Procedure, Drug, Procedure, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2800
Surgical Procedure
2016
Completed Phase 2
~110
Radiation Therapy
2017
Completed Phase 3
~7130
Transabdominal Ultrasound
2020
N/A
~50
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~670
Topotecan
FDA approved
Computed Tomography
2017
Completed Phase 2
~3410
Cyclophosphamide
FDA approved
Beta-D-Glucose
Not yet FDA approved
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Vincristine
FDA approved
Irinotecan
FDA approved
Carboplatin
FDA approved
Ifosfamide
FDA approved
Daunorubicin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from study entry to death due to any cause, assessed up to 5 years after study enrollment
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
451 Previous Clinical Trials
236,850 Total Patients Enrolled
29 Trials studying Wilms Tumor
17,805 Patients Enrolled for Wilms Tumor
National Cancer Institute (NCI)NIH
13,161 Previous Clinical Trials
41,167,162 Total Patients Enrolled
54 Trials studying Wilms Tumor
21,335 Patients Enrolled for Wilms Tumor
James I GellerPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Wilms Tumor
62 Patients Enrolled for Wilms Tumor
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If you had surgery to remove a kidney tumor before joining the study, your doctor must have taken at least one lymph node sample.
You have recently been diagnosed with a rare type of kidney cancer called diffuse anaplastic Wilms tumor, which has been confirmed by an expert.
If you have been diagnosed with a specific type of kidney tumor called diffuse anaplastic Wilms tumor, you need to enroll in the study within two weeks of the procedure that confirmed the diagnosis. This includes patients who were previously diagnosed with a different type of Wilms tumor and later found to have diffuse anaplastic Wilms tumor upon review of the initial biopsy.
You received two chemotherapy drugs (actinomycin D and vincristine) as your first treatment, and your cancer has come back but is not considered high-risk.
You have already undergone three rounds of chemotherapy with specific drugs.
You've already had four or more types of chemotherapy as part of your initial treatment, which included primarily regimen M or its variations.
You must be 30 years old or younger when you join the study.
You have been diagnosed with a specific type of kidney tumor called diffuse anaplastic Wilms tumor and have received an initial risk assessment showing it. If you have a different type of kidney tumor called favorable histology Wilms tumor that has relapsed, you are still eligible to participate.
If you have recently been diagnosed with DAWT, your cancer must have been confirmed by examining a tissue sample. If you have had FHWT before and it has come back, it is recommended that you have another biopsy, but it is not required.
If you previously had favorable histology Wilms tumor and it has returned, we need a report from the hospital confirming this before you can start treatment under this protocol.
Frequently Asked Questions
Are there any locations within the city that are currently conducing this research?
"Currently, participants are being recruited from 100 different sites located in cities such as Springfield, Jacksonville and West Palm Beach. To negate transitory stresses, it is suggested that those interested seek out the closest location available to them for enrollment." - Anonymous Online Contributor
Unverified Answer
Under what circumstances is Ifosfamide typically prescribed?
"Ifosfamide is frequently utilized to treat Hodgkin's Disease, as well as lymphocytic lymphomas, malevolent esophageal neoplasms, and Neuroendocrine Tumours (NETs)." - Anonymous Online Contributor
Unverified Answer
Has the Federal Drug Administration sanctioned any therapeutic uses of Ifosfamide?
"Due to the lack of existing clinical data regarding ifosfamide's efficacy, and its relative safety in Phase 2 trials, our team at Power has awarded it a score of 2." - Anonymous Online Contributor
Unverified Answer
Is this research pioneering in its field?
"As of now, 1950 active trials are underway involving Ifosfamide across the world's 88 countries in 3814 cities. The pioneering investigation for this drug was undertaken by Alfacell back in 1997 with 300 participants and concluded at Phase 3 status. Subsequently, 3217 studies have taken place since then." - Anonymous Online Contributor
Unverified Answer
Are there any precedents for the application of Ifosfamide in clinical trials?
"Ifosfamide was initially investigated at Spectrum Health Hospital - Butterworth Campus in 1997. Since then, a total of 3,217 trials have been completed and 1,950 are ongoing; many of these clinical assessments take place in Springfield, Illinois." - Anonymous Online Contributor
Unverified Answer
Is there presently any recruitment for this clinical experiment?
"Data available on clinicaltrials.gov corroborates that this study is still recruiting participants, having been posted to the website on September 18th 2020 and revised as of October 21st 2022." - Anonymous Online Contributor
Unverified Answer
What is the sample size of this experiment?
"This clinical trial mandates the participation of 221 eligible participants. Southern Illinois University School of Medicine in Springfield and Nemours Children's Clinic-Jacksonville are amongst the available sites for patients to join this experiment." - Anonymous Online Contributor
Unverified Answer