Find-A-Study

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Purpose

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Study Contact

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Eligibility

Eligible Ages: Under29 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Newly diagnosed Wilms' tumor meeting 1 of the following criteria:
- Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
- Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
Patients must begin therapy within 14 days after surgery or biopsy, unless medically contraindicated
No bilateral Wilms' tumors (stage IV)
- Patients should be referred to COG-AREN0534
Previously enrolled in clinical trial COG-AREN03B2
Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST or ALT < 2.5 times ULN
Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
No concurrent aprepitant

Exclusion Criteria

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Condition: Stage III Wilms Tumor With Loss of Heterozygosity (LOH) for 1p and 16q
Stage IV Wilms Tumor

Arm Groups

Arm	Description	Intervention
Experimental Stage IV and rapid complete response (RCR) of lung metastases	Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A	Drug: doxorubicin hydrochloride Given IV Other names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Procedure: conventional surgery Other names: surgery, conventional Biological: dactinomycin Given IV Other names: ACT-D actinomycin C1 AD Cosmegen DACT Drug: liposomal vincristine sulfate Given IV Other names: liposomal vincristine Marqibo vincristine liposomal vincristine sulfate liposome injection
Other Stage III/IV with LOH 1p and 16q treated with Regimen M	Stage III/IV with LOH 1p and 16q treated with Regimen M	Drug: doxorubicin hydrochloride Given IV Other names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Procedure: conventional surgery Other names: surgery, conventional Biological: dactinomycin Given IV Other names: ACT-D actinomycin C1 AD Cosmegen DACT Drug: etoposide Given IV Other names: EPEG VP-16 VP-16-213 Drug: liposomal vincristine sulfate Given IV Other names: liposomal vincristine Marqibo vincristine liposomal vincristine sulfate liposome injection Radiation: 3-dimensional conformal radiation therapy Other names: 3D conformal radiation therapy 3D-CRT Drug: cyclophosphamide Given IV Other names: CPM CTX Cytoxan Endoxan Endoxana
Other Stage IV with lung metastases	Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6	Drug: doxorubicin hydrochloride Given IV Other names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Procedure: conventional surgery Other names: surgery, conventional Biological: dactinomycin Given IV Other names: ACT-D actinomycin C1 AD Cosmegen DACT Drug: liposomal vincristine sulfate Given IV Other names: liposomal vincristine Marqibo vincristine liposomal vincristine sulfate liposome injection
Experimental Stage IV and slow incomplete response (SIR) of lung metastases	Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A	Drug: doxorubicin hydrochloride Given IV Other names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Procedure: conventional surgery Other names: surgery, conventional Biological: dactinomycin Given IV Other names: ACT-D actinomycin C1 AD Cosmegen DACT Drug: etoposide Given IV Other names: EPEG VP-16 VP-16-213 Drug: liposomal vincristine sulfate Given IV Other names: liposomal vincristine Marqibo vincristine liposomal vincristine sulfate liposome injection Radiation: 3-dimensional conformal radiation therapy Other names: 3D conformal radiation therapy 3D-CRT Drug: cyclophosphamide Given IV Other names: CPM CTX Cytoxan Endoxan Endoxana
Other Stage IV with non-lung disease treated with Regimen M	Stage IV with non-lung disease treated with Regimen M	Drug: doxorubicin hydrochloride Given IV Other names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Procedure: conventional surgery Other names: surgery, conventional Biological: dactinomycin Given IV Other names: ACT-D actinomycin C1 AD Cosmegen DACT Drug: etoposide Given IV Other names: EPEG VP-16 VP-16-213 Drug: liposomal vincristine sulfate Given IV Other names: liposomal vincristine Marqibo vincristine liposomal vincristine sulfate liposome injection Drug: cyclophosphamide Given IV Other names: CPM CTX Cytoxan Endoxan Endoxana