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Alkylating agents

Chemotherapy for Wilms Tumor

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

Must not have

Concomitant use of St. John's wort

Relapsed FHWT patients who did not receive frontline chemotherapy or received only one chemotherapy agent for frontline therapy

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

No Placebo-Only Group

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.

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.

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

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I am 30 years old or younger.

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My heart is functioning within the required range.

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

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

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

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using St. John's wort.

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My FHWT has returned and I've had limited or no initial chemotherapy.

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I have kidney problems related to acid levels due to my high-risk kidney cancer.

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I am currently pregnant or breastfeeding.

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I do not have any uncontrolled illnesses.

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I have had Wilms tumor in both of my kidneys.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Secondary study objectives

Overall survival (OS)

Other study objectives

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

PYREXIA

STOMATITIS

DEVICE RELATED INFECTION

GENERALISED TONIC-CLONIC SEIZURE

SEPSIS

VOMITING

MUCOSAL INFLAMMATION

CHEMOTHERAPEUTIC DRUG LEVEL INCREASED

DRUG CLEARANCE DECREASED

CLOSTRIDIUM DIFFICILE COLITIS

TIBIA FRACTURE

100%

80%

60%

40%

20%

Study treatment Arm

MAP-GR

MAPifn

MAPIE

MAP-PR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cyclophosphamide

2010

Completed Phase 4

~2310

Magnetic Resonance Imaging

2017