Purpose

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.

Category

IRB Number
20090514HU
NCT Number
NCT00945009
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



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

    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
    1. Adult Kidney Wilms Tumor
    2. Beckwith-Wiedemann Syndrome
    3. Childhood Kidney Wilms Tumor
    4. Diffuse Hyperplastic Perilobar Nephroblastomatosis
    5. Hemihypertrophy
    6. Rhabdoid Tumor of the Kidney
    7. Stage I Kidney Wilms Tumor
    8. Stage II Kidney Wilms Tumor
    9. Stage III Kidney Wilms Tumor
    10. Stage IV Kidney Wilms Tumor
    11. Stage V Kidney Wilms Tumor
    12. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Arm 1 (Bilateral Wilms Tumors)

      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.
    13. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Procedure: Therapeutic Conventional Surgery

        Undergo surgical resection

      • Biological: Dactinomycin

        Given IV

        Other names:

        • Actinomycin A IV
        • Actinomycin C1
        • ACTINOMYCIN D
        • Actinomycin I1
        • Actinomycin IV
        • Actinomycin X 1
        • Actinomycin-[thr-val-pro-sar-meval]
        • Cosmegen
        • DACT
        • Dactinomy

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • Irradiate
        • Irradiated
        • irradiation
        • Radiation
        • Radiotherapeutics
        • RADIOTHERAPY
        • RT
        • Therapy, Radiation

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

    14. Experimental

      Arm 3 (DHPLN)

      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.
    15. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Procedure: Therapeutic Conventional Surgery

        Undergo surgical resection

      • Biological: Dactinomycin

        Given IV

        Other names:

        • Actinomycin A IV
        • Actinomycin C1
        • ACTINOMYCIN D
        • Actinomycin I1
        • Actinomycin IV
        • Actinomycin X 1
        • Actinomycin-[thr-val-pro-sar-meval]
        • Cosmegen
        • DACT
        • Dactinomy

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • Irradiate
        • Irradiated
        • irradiation
        • Radiation
        • Radiotherapeutics
        • RADIOTHERAPY
        • RT
        • Therapy, Radiation

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

    16. Experimental

      Arm 2 (Unilateral High Risk tumors bilaterally predisposed)

      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.
    17. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Procedure: Therapeutic Conventional Surgery

        Undergo surgical resection

      • Biological: Dactinomycin

        Given IV

        Other names:

        • Actinomycin A IV
        • Actinomycin C1
        • ACTINOMYCIN D
        • Actinomycin I1
        • Actinomycin IV
        • Actinomycin X 1
        • Actinomycin-[thr-val-pro-sar-meval]
        • Cosmegen
        • DACT
        • Dactinomy

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • Irradiate
        • Irradiated
        • irradiation
        • Radiation
        • Radiotherapeutics
        • RADIOTHERAPY
        • RT
        • Therapy, Radiation

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate