Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00352534

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

Official Title:

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Summary

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

Eligibility

Inclusion Criteria:

* Histologically confirmed Wilms' tumor

* Newly diagnosed stage I-III disease
* Favorable histology
* No moderate- or high-risk Wilms' predisposition syndromes
* Must meet 1 of the following disease stratification categories:

* Very low-risk disease

* Stage I disease
* Age \< 2 years
* Tumor weight \< 550 g
* Regional lymph nodes histologically negative (must have been sampled)
* No pulmonary metastases on CT scan of chest
* No synchronous bilateral Wilms tumors (Stage V)
* Not predisposed to develop bilateral Wilms tumors, defined as unilateral Wilms tumor and any of the following:

* Aniridia
* Beckwith-Wiedemann syndrome
* Simpson-Golabi-Behmel syndrome
* Denys-Drash syndrome or other associated genito-urinary anomalies
* Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a child \< 1 year of age
* Diffuse hyperplastic perilobar nephroblastomatosis
* Standard-risk disease meeting 1 of the following criteria:

* Disease does not require radiotherapy

* LOH at chromosomes 1p and 16q for stage I or II
* Stage I disease meeting 1 of the following criteria:

* Age ≥ 2 years to age \< 30 years
* Tumor weight ≥ 500 g
* Stage II disease

* Age \< 30 years
* Any tumor weight
* Disease requires radiotherapy

* No LOH at chromosomes 1p and 16q\*
* Stage III disease
* Must be enrolled on protocol COG-AREN03B2
* Karnofsky performance status (PS) 50-100% for patients \> 16 years old
* Lansky PS 50-100% for patients ≤ 16 years old
* Bilirubin (direct) ≤ 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 (standard-risk disease)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patient must use effective contraception
* No prior tumor-directed chemotherapy or radiotherapy

* Patients transferring from AREN03B2 with LOH 1p and 16q allowed

Disease(s) and\or Condition(s)

Stage I Kidney Wilms Tumor

Stage II Kidney Wilms Tumor

Stage III Kidney Wilms Tumor

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: RADIATION
    • Name: 3-Dimensional Conformal Radiation Therapy
    • Description: Patients undergo radiotherapy
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Biospecimen Collection
    • Description: Undergo blood sample collection
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Chest Radiography
    • Description: Undergo chest X-ray
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Computed Tomography
    • Description: Undergo CT
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: BIOLOGICAL
    • Name: Dactinomycin
    • Description: Given IV
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: DRUG
    • Name: Doxorubicin Hydrochloride
    • Description: Given IV
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Echocardiography
    • Description: Undergo echocardiography
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Magnetic Resonance Imaging
    • Description: Undergo MRI
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Therapeutic Conventional Surgery
    • Description: Undergo surgery
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: PROCEDURE
    • Name: Ultrasound Imaging
    • Description: Undergo ultrasound
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
    • Type: DRUG
    • Name: Vincristine Sulfate
    • Description: Given IV
    • Arm Group Labels: Stratum I (very low-risk disease), Stratum II (standard-risk, stage I or II), Stratum III (standard-risk, stage III)
Sponsor
  • Children's Oncology Group