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Anti-tumor antibiotic

Chemotherapy + Surgery for Kidney Cancer (Wilms Tumor)

Phase 3

Waitlist Available

Led By Peter Ehrlich

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

Total bilirubin =< 1.5 times upper limit of normal (ULN) for age

Patients must not have undergone nephrectomy at diagnosis for certain specified conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years from study enrollment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial looks at a combination of chemotherapy drugs and surgery to treat Wilms tumor in young patients.

Who is the study for?

This trial is for young patients with Wilms tumor who haven't had chemotherapy or radiation before. They must have normal liver function and heart performance, agree to use contraception if applicable, and not be breastfeeding. Patients need to sign consent forms and meet all study requirements.

What is being tested?

The trial tests how well a combination of chemotherapy drugs (Doxorubicin Hydrochloride, Vincristine Sulfate, Dactinomycin) plus surgery works in treating Wilms tumor. The aim is to see if this approach can shrink the tumor before surgery or eliminate remaining cells after.

What are the potential side effects?

Chemotherapy drugs may cause side effects like nausea, vomiting, hair loss, mouth sores, fatigue, infection risk increase due to low blood cell counts; Doxorubicin specifically can affect the heart.

Eligibility Criteria

Inclusion Criteria

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

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My bilirubin levels are within normal range for my age.

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I have not had my kidney removed at diagnosis for specific conditions.

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I am mostly able to care for myself, regardless of my age.

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I am willing to stop breastfeeding if I join the trial.

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I am not currently taking aprepitant.

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My heart's pumping ability is within a healthy range.

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I have one of the conditions listed for the trial.

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I have not had chemotherapy or radiation before this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years from 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)

Kidney Preservation After Preoperative Chemotherapy

Number of Patients Without Complete Removal of at Least One Kidney

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3 (DHPLN)Experimental Treatment5 Interventions

Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.

Group II: Arm 2 (Unilateral High Risk tumors bilaterally predisposed)Experimental Treatment5 Interventions

Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.

Group III: Arm 1 (Bilateral Wilms Tumors)Experimental Treatment5 Interventions

Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860

Radiation Therapy

2017

Completed Phase 3

~7250