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

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00335556

Purpose

RATIONALE: 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.

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.

Condition	Intervention	Phase
Kidney Cancer	Biological: dactinomycin Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: irinotecan hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Treatment of High Risk Renal Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer Surgery Wilms' Tumor

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Irinotecan U 101440E Etoposide phosphate Irinotecan hydrochloride Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free and overall survival [ Designated as safety issue: No ]
Antitumor activity [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Correlation of histologic and molecular cytogenetic findings with outcome [ Designated as safety issue: No ]
Response rate in patients with distantly metastatic RCC treated according to institutional preference [ Designated as safety issue: No ]
Frequency of INI1 mutations in renal and extrarenal malignant rhabdoid tumor [ Designated as safety issue: No ]
Frequency of TP53 mutations in patients with anaplastic Wilms' tumor [ Designated as safety issue: No ]
Correlation of detectable TP53 mutation with clinical outcome in patients with anaplastic Wilms' tumor [ Designated as safety issue: No ]

Estimated Enrollment:	295
Study Start Date:	June 2006
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Surgery: Experimental 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
Regimen UH-1: Experimental 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: carboplatin Given IV Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: vincristine sulfate Given IV Procedure: conventional surgery Patients undergo resection Radiation: radiation therapy Patients undergo radiotherapy 5 days a week
Irinotecan/vincristine window therapy: Experimental 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: carboplatin Given IV Drug: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: irinotecan hydrochloride Given IV Drug: vincristine sulfate Given IV Procedure: conventional surgery Patients undergo resection Radiation: radiation therapy Patients undergo radiotherapy 5 days a week
Regimen UH-2: Experimental 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: carboplatin Given IV Drug: irinotecan hydrochloride Given IV Procedure: conventional surgery Patients undergo resection Radiation: radiation therapy Patients undergo radiotherapy 5 days a week
Regimen I: Experimental 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: cyclophosphamide Given IV Drug: doxorubicin hydrochloride Given IV Drug: etoposide Given IV Drug: vincristine sulfate Given IV Procedure: conventional surgery Patients undergo resection Radiation: radiation therapy Patients undergo radiotherapy 5 days a week
Regimen DD-4A: Experimental 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.	Biological: dactinomycin Given IV Drug: doxorubicin hydrochloride Given IV Drug: vincristine sulfate Given IV Procedure: conventional surgery Patients undergo resection Radiation: radiation therapy Patients undergo radiotherapy 5 days a week

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Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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
High-risk disease
Stage I-IV disease
- No stage V (bilateral) high-risk renal tumors
Patients with stage IV diffuse anaplastic Wilms' tumor are eligible for "window" therapy if the following criteria are met:
- Measurable disease, defined as ≥ 1 lesion that can be measured in 3 dimensions with the longest diameter (which may be in the cranio-caudal dimension) ≥ 1 cm on CT scan or MRI
- No tumors that could potentially cause life-threatening complications with tumor progression, such as tumors with intracranial or intraspinal extension
- No tumors that could compress the airway
No CNS tumors
Enrolled on COG-AREN03B2

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (≤ 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 LVEF ≥ 50%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No prior systemic chemotherapy or radiation therapy unless enrolled on COG-AREN0532 or COG-AREN0533 clinical trials and received prenephrectomy chemotherapy
- Patients with renal cell carcinoma who received prior chemotherapy for another type of malignancy or non-malignant condition allowed
- Patients who received prior chemotherapy are not eligible for "window" therapy
No more than 14 days since prior surgery or biopsy unless medically contraindicated or pathological diagnosis requires special studies
No concurrent aprepitant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335556

Show 154 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Jeffrey S. Dome, MD	Children's Research Institute
Investigator:	Najat C. Daw, MD	St. Jude Children's Research Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers:	CDR0000472893, COG-AREN0321
Study First Received:	June 8, 2006
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00335556 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I Wilms tumor
stage II Wilms tumor
stage III Wilms tumor
stage IV Wilms tumor
clear cell renal cell carcinoma
rhabdoid tumor of the kidney
stage I renal cell cancer

stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
clear cell sarcoma of the kidney
childhood renal cell carcinoma
papillary renal cell carcinoma

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Irinotecan
Urogenital Neoplasms
Cyclophosphamide
Urologic Neoplasms
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Neoplasms by Site
Urologic Diseases
Dactinomycin
Kidney Neoplasms

Therapeutic Uses
Kidney Diseases
Alkylating Agents
Etoposide
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Doxorubicin
Camptothecin
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010