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Anti-tumor antibiotic

Chemotherapy +/− Radiation for Kidney Cancer

Phase 3

Waitlist Available

Led By Conrad V Fernandez

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

Any tumor weight

Must meet 1 of the following disease stratification categories:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is studying whether giving vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only is effective in treating patients with Wilms' tumor.

Who is the study for?

This trial is for young patients who've had surgery for a newly diagnosed Wilms' tumor, which is a type of kidney cancer. It's open to those with stage I-III disease, under 30 years old, and without certain genetic syndromes or bilateral tumors. Patients must not be pregnant, should use contraception if fertile, and have not received prior tumor treatments.Check my eligibility

What is being tested?

The study tests the effectiveness of chemotherapy drugs vincristine, dactinomycin, and doxorubicin after surgery. Some patients may also receive radiation therapy or just observation. The goal is to see if these treatments can eliminate any remaining cancer cells post-surgery.See study design

What are the potential side effects?

Chemotherapy drugs like vincristine, dactinomycin, and doxorubicin can cause side effects such as nausea, hair loss, mouth sores, low blood cell counts increasing infection risk; while radiation might lead to skin irritation at the treatment site.

Eligibility Criteria

Inclusion Criteria

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

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My tumor has a measurable weight.

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My condition fits into one of the required disease categories.

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I have not had chemotherapy or radiotherapy for my tumor.

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My condition is considered very low-risk.

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I am transferring from AREN03B2 with specific genetic changes.

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I have Denys-Drash syndrome or similar urinary tract issues.

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My cancer is in the early stage (Stage I).

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My condition is considered standard-risk.

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I am under 2 years old.

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

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My lymph nodes do not have cancer, confirmed by a biopsy.

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My cancer is in an early to mid-stage (I-III).

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I have aniridia.

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My tumor weighs less than 550 grams.

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I do not have Wilms tumors in both kidneys at the same time.

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I am between 2 and 29 years old.

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My genetic test shows no loss on chromosomes 1p and 16q.

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My condition is in the early stage (Stage I).

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My child can do most activities but may need assistance.

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My condition is at stage III.

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I have Beckwith-Wiedemann syndrome.

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My condition does not need radiation treatment.

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I have been diagnosed with Simpson-Golabi-Behmel syndrome.

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My early-stage cancer shows specific genetic changes.

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My condition is at stage II.

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I do not have a high-risk genetic condition for kidney cancer.

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My condition is confirmed as Wilms' tumor.

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My cancer has a favorable cell type.

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I have a unilateral Wilms tumor without risk factors for developing it on both sides.

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My child under 1 year has a specific kidney condition.

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I am younger than 30 years old.

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My condition needs radiation treatment.

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I am over 16 and can do most activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

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

Overall Survival (OS) Probability

Secondary outcome measures

Incidence of Contralateral Kidney Lesions

Incidence of Renal Failure

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum III (standard-risk, stage III)Experimental Treatment5 Interventions

Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks.

Group II: Stratum II (standard-risk, stage I or II)Experimental Treatment5 Interventions

Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks.

Group III: Stratum I (very low-risk disease)Experimental Treatment5 Interventions

Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7160

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Vincristine Sulfate

2005

Completed Phase 3

~10110

Dactinomycin

2010

Completed Phase 3

~1310

0 / 33Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

236,892 Total Patients Enrolled

1 Trials studying Kidney Wilms Tumor

8,000 Patients Enrolled for Kidney Wilms Tumor

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,345 Total Patients Enrolled

1 Trials studying Kidney Wilms Tumor

8,000 Patients Enrolled for Kidney Wilms Tumor

Conrad V FernandezPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

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

Has the FDA rubber-stamped doxorubicin hydrochloride for public use?

"Doxorubicin hydrochloride is considered safe according to our team's 3-point scale. This medication has progressed to Phase 3 clinical trials, meaning that there is both efficacy and safety data available."

Answered by AI

Can you tell me about other experiments that have used doxorubicin hydrochloride?

"Doxorubicin hydrochloride was first studied in 1997 at the Spectrum Health Hospital - Butterworth Campus. So far, 904 completed studies have been conducted. Additionally, 479 clinical trials are actively recruiting patients as of now. Many of these trials are based in Indianapolis, Indiana."

Answered by AI

Does this trial explore novel territory?

"479 clinical trials using doxorubicin hydrochloride are currently underway in 2088 cities and 69 countries. The first trial began in 1997, 300 participants were enrolled, and it completed Phase 3 drug approval in 1997. Since then, 904 similar studies have been completed."

Answered by AI

What are some of the more common treatments that doxorubicin hydrochloride is used for?

"Doxorubicin hydrochloride is a medication used to treat several conditions, the most common being malignant neoplasm of testis. It can also be effective in treating Kaposi's sarcoma AIDS related, neoplasm metastasis, and acquired immunodeficiency syndrome."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children’s Oncology Group AREN0532 and AREN0533 Study Report

Dix, David B., Conrad V. Fernandez, Yueh-Yun Chi, Elizabeth A. Mullen, James I. Geller, Eric J. Gratias, Geetika Khanna, et al.. 2019. “Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children’s Oncology Group AREN0532 and AREN0533 Study Report”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.18.01972.

Annals of SurgeryJournal

Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor

Fernandez, Conrad V., Elizabeth J. Perlman, Elizabeth A. Mullen, Yueh-Yun Chi, Thomas E. Hamilton, Kenneth W. Gow, Fernando A. Ferrer, et al.. 2017. “Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000001716.

Journal of Clinical OncologyJournal

Outcome and Prognostic Factors in Stage III Favorable-histology Wilms Tumor: A Report from the Children’s Oncology Group Study AREN0532

Fernandez, Conrad V., Elizabeth A. Mullen, Yueh-Yun Chi, Peter F. Ehrlich, Elizabeth J. Perlman, John A. Kalapurakal, Geetika Khanna, et al.. 2018. “Outcome and Prognostic Factors in Stage III Favorable-histology Wilms Tumor: A Report from the Children’s Oncology Group Study AREN0532”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.73.7999.

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