Trial record 2 of 164 for:    "Wilms tumor"

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00945009
First received: July 22, 2009
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Bilateral Wilms tumor and children who are a special risk for forming tumors in both kidneys. 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. 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.


Condition Intervention Phase
Diffuse Hyperplastic Perilobar Nephroblastomatosis
Stage I Wilms Tumor
Stage II Wilms Tumor
Stage III Wilms Tumor
Stage IV Wilms Tumor
Stage V Wilms Tumor
Drug: doxorubicin hydrochloride
Procedure: therapeutic conventional surgery
Biological: dactinomycin
Drug: cyclophosphamide
Drug: carboplatin
Drug: etoposide phosphate
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Prevention of complete removal of at least one kidney in 50% of patients with bilateral Wilms tumor (BWT) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Efficacy of chemotherapy in preserving renal units and preventing Wilms tumor development in patients with diffuse hyperplastic perilobular nephrogenic rests [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Facilitation of partial nephrectomy in lieu of total nephrectomy in 25% of patients with unilateral Wilms tumor [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with BWT undergoing definitive surgical treatment by week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: July 2009
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy, radiation therapy, surgery)
See Detailed Description
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Procedure: therapeutic conventional surgery
Undergo surgical resection
Biological: dactinomycin
Given IV
Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Procedure: adjuvant therapy
Undergo adjuvant therapy
Procedure: neoadjuvant therapy
Undergo neoadjuvant therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients must be < 30 years old at the time of initial diagnosis. Patients must be previously enrolled on AREN03B2 and confirmed to be eligible for AREN0534.

The patient must have one of the following conditions to be eligible for AREN0534:

  1. Synchronous bilateral Wilms tumors*; or
  2. Unilateral Wilms tumor and aniridia, Beckwith-Wiedemann Syndrome, idiopathic hemihypertrophy, Simpson-Golabi-Behmel-Syndrome, Denys-Drash Syndrome or other associated genitourinary anomalies associated with bilateral Wilms tumor, such as hypospadias and undescended testis (to be eligible, these patients must not undergo any nephrectomy at diagnosis; Note-horseshoe kidney is not associated with bilateral Wilms tumor and these patients should go on the appropriate unilateral Wilms tumor study); or
  3. Multicentric Wilms tumor (any age) (to be eligible, these patients must not undergo any nephrectomy at diagnosis); or
  4. Unilateral Wilms tumor with contralateral nephrogenic rest(s) (any size) in a child under one year of age (to be eligible, these patients must not undergo any nephrectomy at diagnosis); or
  5. Diffuse hyperplastic perilobar nephroblastomatosis (unilateral or bilateral) defined by central radiological review; or
  6. Wilms tumor arising in a solitary kidney (patients with metachronous Wilms tumor are not eligible).

(*) It is often difficult to distinguish Wilms tumors from nephrogenic rests based on imaging studies and percutaneous biopsies. The AREN0534 study uses the guideline that Wilms tumor with a single lesion 1 cm or greater in the contralateral kidney or multiple lesions (of any size) in the contralateral kidney should be treated on the synchronous bilateral Wilms tumor stratum. Patients with an isolated lesion less than 1 cm in the contralateral kidney should be treated on the appropriate study for unilateral Wilms tumor OR on the unilateral Wilms tumor/contralateral nephrogenic rest stratum of this study if they have not undergone nephrectomy and are under one year of age.

Loss of heterozygosity (LOH) results—which are used in the unilateral Wilms tumor studies—are not a requirement for enrollment on AREN0534. Blood samples can be submitted but will not be used to direct AREN0534 therapy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945009

  Show 148 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Peter Ehrlich, MD MSC Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00945009     History of Changes
Other Study ID Numbers: AREN0534, NCI-2011-01953, CDR0000649716, U10CA098543, COG-AREN0534
Study First Received: July 22, 2009
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wilms Tumor
Hyperplasia
Pathologic Processes
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn
Dactinomycin
Doxorubicin
Etoposide phosphate
Cyclophosphamide
Etoposide
Vincristine
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014