Chemotherapy + Surgery for Kidney Cancer (Wilms Tumor)

Recruiting in Palo Alto (17 mi)

+190 other locations

Overseen byPeter F Ehrlich

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Research Team

Peter F Ehrlich

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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.

Inclusion Criteria

My bilirubin levels are within normal range for my age.

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

I am of childbearing age and have a negative pregnancy test.

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Treatment Details

Interventions

Dactinomycin (Anti-tumor antibiotic)
Doxorubicin Hydrochloride (Anti-tumor antibiotic)
Radiation Therapy (Radiation)
Therapeutic Conventional Surgery (Surgery)
Vincristine Sulfate (Vinca alkaloids)

Trial OverviewThe 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.

Participant Groups

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.

Dactinomycin is already approved in Canada for the following indications: