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Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00335556
First received: June 8, 2006
Last updated: May 12, 2017
Last verified: April 2016
  Purpose
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Condition Intervention Phase
Childhood Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Clear Cell Sarcoma of the Kidney Papillary Renal Cell Carcinoma Rhabdoid Tumor of the Kidney Stage I Renal Cell Cancer Stage I Renal Wilms Tumor Stage II Renal Cell Cancer Stage II Renal Wilms Tumor Stage III Renal Cell Cancer Stage III Renal Wilms Tumor Stage IV Renal Cell Cancer Stage IV Renal Wilms Tumor Drug: Doxorubicin Hydrochloride Drug: Irinotecan Hydrochloride Procedure: Conventional Surgery Drug: Cyclophosphamide Drug: Etoposide Drug: Carboplatin Biological: Dactinomycin Drug: Vincristine Sulfate Radiation: Radiation Therapy Other: Laboratory Biomarker Analysis Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Treatment of High Risk Renal Tumors: A Groupwide Phase II Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT) [ Time Frame: 4 years ]
    Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS‐5.

  • Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors [ Time Frame: 4 years ]
    The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen.

  • Response Rate [ Time Frame: Up to 2 months ]
    Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non‐index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.

  • Event Free Survival Probability [ Time Frame: 4 years ]
    Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5.

  • Toxicity Rate [ Time Frame: Up to 4 years ]
    Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.


Secondary Outcome Measures:
  • Frequency of INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization [ Time Frame: At baseline ]
  • Frequency of TP53 Mutations [ Time Frame: At baseline ]

Enrollment: 291
Study Start Date: June 2006
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional
Experimental: Treatment (UH-1)
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.
Drug: Doxorubicin Hydrochloride
Given IV
Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional
Drug: Cyclophosphamide
Given IV
Drug: Etoposide
Given IV
Other Name: Lastet
Drug: Carboplatin
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Radiation: Radiation Therapy
Undergo radiotherapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Treatment (window/UH-1)
Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Irinotecan Hydrochloride
Given IV
Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional
Drug: Cyclophosphamide
Given IV
Drug: Etoposide
Given IV
Other Name: Lastet
Drug: Carboplatin
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Radiation: Radiation Therapy
Undergo radiotherapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Treatment (UH-2)
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Irinotecan Hydrochloride
Given IV
Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional
Drug: Etoposide
Given IV
Other Name: Lastet
Drug: Carboplatin
Given IV
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Radiation: Radiation Therapy
Undergo radiotherapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Treatment (regimen I)
Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Drug: Doxorubicin Hydrochloride
Given IV
Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional
Drug: Cyclophosphamide
Given IV
Drug: Etoposide
Given IV
Other Name: Lastet
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Radiation: Radiation Therapy
Undergo radiotherapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Treatment (regimen DD-4A)
Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Drug: Doxorubicin Hydrochloride
Given IV
Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional
Biological: Dactinomycin
Given IV
Other Name: Lyovac Cosmegen
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Radiation: Radiation Therapy
Undergo radiotherapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Other: Laboratory Biomarker Analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed disease of 1 of the following histologic types:

    • Focal anaplastic Wilms' tumor
    • Diffuse anaplastic Wilms' tumor
    • Clear cell sarcoma of the kidney
    • Malignant rhabdoid tumor (renal or extrarenal)
    • Renal cell carcinoma

      • Clear cell
      • Papillary
      • Renal medullary
      • Oncocytoid
      • Sarcomatoid
      • Chromophobe
      • Translocation
      • Collecting duct
      • Carcinoma associated with neuroblastoma
      • Renal cell carcinoma unclassified
  • Specimens/materials must be submitted for central review by Day 7
  • Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated
  • Karnofsky performance status (PS) must be >= 50 for patients > 16 years if age and Lansky PS must be >= 50 for patients =< 16 years of age
  • Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study
  • Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ ALT]) < 2.5 times ULN for age
  • Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram
  • Female patients of childbearing age must have a negative pregnancy test
  • Female patients who are lactating must agree to stop breast-feeding
  • Sexually active patients of childbearing potential must agree to use effective contraception
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  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: NCT00335556

  Show 187 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey Dome, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00335556     History of Changes
Other Study ID Numbers: AREN0321
NCI-2009-00414 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AREN0321 ( Other Identifier: Children's Oncology Group )
CDR0000472893 ( Other Identifier: ClinicalTrials.gov )
AREN0321 ( Other Identifier: Children's Oncology Group )
AREN0321 ( Other Identifier: CTEP )
U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received: June 8, 2006
Results First Received: November 28, 2016
Last Updated: May 12, 2017

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Wilms Tumor
Rhabdoid Tumor
Kidney Neoplasms
Sarcoma, Clear Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Cyclophosphamide
Etoposide phosphate
Liposomal doxorubicin
Irinotecan
Carboplatin
Etoposide
Doxorubicin
Dactinomycin
Vincristine

ClinicalTrials.gov processed this record on June 28, 2017