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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

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 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

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
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Vincristine Sulfate
2005
Completed Phase 3
~10270
Dactinomycin
2010
Completed Phase 3
~1310

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,581 Total Patients Enrolled
1 Trials studying Kidney Wilms Tumor
8,000 Patients Enrolled for Kidney Wilms Tumor
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,751 Total Patients Enrolled
1 Trials studying Kidney Wilms Tumor
8,000 Patients Enrolled for Kidney Wilms Tumor
Peter EhrlichPrincipal InvestigatorChildren's Oncology Group

Media Library

Dactinomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00945009 — Phase 3
Kidney Wilms Tumor Research Study Groups: Arm 2 (Unilateral High Risk tumors bilaterally predisposed), Arm 3 (DHPLN), Arm 1 (Bilateral Wilms Tumors)
Kidney Wilms Tumor Clinical Trial 2023: Dactinomycin Highlights & Side Effects. Trial Name: NCT00945009 — Phase 3
Dactinomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00945009 — Phase 3
~15 spots leftby Sep 2025
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