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Alkylating agents

Chemotherapy for Wilms Tumor

Q: 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.

Q: 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).

Q: 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.

Q: 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.

Q: 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, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>.

Q: 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.

Q: What is the sample size of this experiment?

This clinical trial mandates the participation of 221 eligible participants. Southern <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> University School of Medicine in Springfield and Nemours Children's Clinic-Jacksonville are amongst the available sites for patients to join this experiment.

Phase 2

Recruiting

Led By James I Geller

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

Patients must be =< 30 years old at study enrollment

Patients must meet specific criteria for cardiac function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study entry to death due to any cause, assessed up to 5 years after study enrollment

Awards & highlights

Study Summary

This trial is studying two chemotherapy regimens to treat patients with Wilms tumor.

Who is the study for?

This trial is for individuals up to 30 years old with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors or those whose favorable histology Wilms tumor has relapsed. They must have a certain level of physical ability, life expectancy over 8 weeks, and meet specific health criteria including heart, blood count, kidney and liver function. Pregnant women, patients with bilateral tumors or uncontrolled illnesses are excluded.Check my eligibility

What is being tested?

The study tests combination chemotherapy regimens UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide & irinotecan) for new DAWT cases & ICE/Cyclo/Topo (ifosfamide, carboplatin etoposide cyclophosphamide & topotecan) for high-risk relapsed FHWT. It aims to see how these drugs affect tumor growth by killing cells or stopping them from dividing/spreading.See study design

What are the potential side effects?

Potential side effects include hair loss; nausea; vomiting; mouth sores; diarrhea; increased risk of infection due to low white blood cell counts; bleeding or bruising from low platelets; tiredness and weakness from anemia. Heart problems may also occur due to some drugs used in the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 30 years old or younger.

Select...

My heart is functioning within the required range.

Select...

My diagnosis is stage 2-4 diffuse anaplastic Wilms tumor or it's a first relapse of favorable histology Wilms tumor.

Select...

I have a specific type of kidney cancer and am enrolled in a specific study.

Select...

My blood, kidney, and liver tests meet the required levels.

Select...

I have relapsed Wilms tumor and haven't had chemotherapy for the relapse.

Select...

I can take care of myself but may not be able to do heavy physical work.

Select...

My diagnosis of diffuse anaplastic Wilms' tumor was confirmed through tissue examination.

Select...

I have a specific type of kidney cancer and joined a study within 2 weeks after my surgery or biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry to the earliest of relapse or disease progression, second malignant neoplasm, or death from any cause, assessed up to 5 years after study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free survival (EFS)

Secondary outcome measures

Overall survival (OS)

Other outcome measures

Association of the number of nodes examined with EFS and OS

Collection of blood and urine samples

EFS for patients with gross total disease resection

+3 more

Side effects data

From 2022 Phase 3 trial • 1334 Patients • NCT00134030

FEBRILE NEUTROPENIA

CHEMOTHERAPEUTIC DRUG LEVEL INCREASED

SEPSIS

VOMITING

MUCOSAL INFLAMMATION

STOMATITIS

PYREXIA

DEVICE RELATED INFECTION

GENERALISED TONIC-CLONIC SEIZURE

DRUG CLEARANCE DECREASED

CLOSTRIDIUM DIFFICILE COLITIS

TIBIA FRACTURE

100%

80%

60%

40%

20%

Study treatment Arm

MAP-GR

MAPifn

MAPIE

MAP-PR

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (Regimen ICE/Cyclo/Topo)Experimental Treatment15 Interventions

CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity. CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.

Group II: Arm I (Regimen UH-3)Experimental Treatment15 Interventions

See outline in detailed description section.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Transabdominal Ultrasound

2020

N/A

~50

Surgical Procedure

2020

Completed Phase 2

~160

Positron Emission Tomography

2008

Completed Phase 2

~2240

Radiation Therapy

2017

Completed Phase 3

~7250

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1730

Topotecan

2017

Completed Phase 3

~2400

Computed Tomography

2017

Completed Phase 2

~2720

Cyclophosphamide

1995

Completed Phase 3

~3770

Etoposide

2010

Completed Phase 3

~2440

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Vincristine

2003

Completed Phase 4

~2910

Irinotecan

2017

Completed Phase 4

~2680

Ifosfamide

2010

Completed Phase 4

~2980

Doxorubicin

2012

Completed Phase 3

~7940

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,719 Total Patients Enrolled

29 Trials studying Wilms Tumor

17,805 Patients Enrolled for Wilms Tumor

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,660 Total Patients Enrolled

54 Trials studying Wilms Tumor

21,187 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

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04322318 — Phase 2

Wilms Tumor Research Study Groups: Arm II (Regimen ICE/Cyclo/Topo), Arm I (Regimen UH-3)

Wilms Tumor Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04322318 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322318 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

2020. "A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322318.

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