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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335556 |
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 |
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Kidney Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: irinotecan hydrochloride Drug: vincristine sulfate Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of High Risk Renal Tumors |
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 |
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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.
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Procedure: conventional surgery
Patients undergo resection
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Regimen UH-1: Experimental
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients also receive filgrastim (G-CSF). 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.
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Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: filgrastim
Given subcutaneously or IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Patients undergo resection
Procedure: radiation therapy
Patients undergo radiotherapy 5 days a week
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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.
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Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: filgrastim
Given subcutaneously or IV
Drug: irinotecan hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Patients undergo resection
Procedure: 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 also receive G-CSF as in regimen UH-1. 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.
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Drug: carboplatin
Given IV
Drug: filgrastim
Given subcutaneously or IV
Drug: irinotecan hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo resection
Procedure: radiation therapy
Patients undergo radiotherapy 5 days a week
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Regimen I: Experimental
Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients also receive G-CSF as in regimen UH-1. 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: filgrastim
Given subcutaneously or IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Patients undergo resection
Procedure: 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.
|
Drug: dactinomycin
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Patients undergo resection
Procedure: radiation therapy
Patients undergo radiotherapy 5 days a week
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Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed disease of 1 of the following histologic types:
Renal cell carcinoma
Stage I-IV disease
Patients with stage IV diffuse anaplastic Wilms' tumor are eligible for "window" therapy if the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy or radiation therapy unless enrolled on COG-AREN0532 or COG-AREN0533 clinical trials and received prenephrectomy chemotherapy
Study Chair: | Jeffrey S. Dome, MD | Childrens Research Institute |
Investigator: | Najat C. Daw, MD | St. Jude Children's Research Hospital |
Study ID Numbers: | CDR0000472893, COG-AREN0321 |
Study First Received: | June 8, 2006 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00335556 |
Health Authority: | Unspecified |
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 |
Rhabdoid Tumor Malignant mesenchymal tumor Irinotecan Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Kidney cancer Etoposide phosphate Soft tissue sarcomas Chromophil renal cell carcinoma Urologic Diseases Kidney Neoplasms Dactinomycin Wilms Tumor Kidney Diseases |
Clear cell renal cell carcinoma Etoposide Wilms' tumor Vincristine Sarcoma, Clear Cell Carboplatin Renal cancer Camptothecin Doxorubicin Carcinoma Rhabdoid tumor Carcinoma, Renal Cell Sarcoma Papillary renal cell carcinoma Adenocarcinoma |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Protein Synthesis Inhibitors Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Nucleic Acid Synthesis Inhibitors |