Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
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| ClinicalTrials.gov Identifier: NCT00335556 |
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Recruitment Status :
Completed
First Posted : June 12, 2006
Results First Posted : June 14, 2017
Last Update Posted : July 21, 2017
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief Summary:
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 or disease | Intervention/treatment | 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 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 291 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of High Risk Renal Tumors: A Groupwide Phase II Study |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | December 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Wilms tumor
MedlinePlus related topics:
Kidney Cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: Conventional Surgery
Patients undergo resection
Other Name: surgery, conventional |
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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.
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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:
Radiation: Radiation Therapy Undergo radiotherapy
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
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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.
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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:
Radiation: Radiation Therapy Undergo radiotherapy
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
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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.
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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:
Radiation: Radiation Therapy Undergo radiotherapy
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
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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:
Radiation: Radiation Therapy Undergo radiotherapy
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
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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.
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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:
Radiation: Radiation Therapy Undergo radiotherapy
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies |
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 (NCT00002610).
- 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 (NCT00002610).
- 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 (NCT00002610).
- 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 :
- Number of Patients With 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 ]
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| Ages Eligible for Study: | up to 29 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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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)
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335556
Locations
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 |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00335556 |
| 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 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 12, 2006 Key Record Dates |
| Results First Posted: | June 14, 2017 |
| Last Update Posted: | July 21, 2017 |
| Last Verified: | April 2016 |
Additional relevant MeSH terms:
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Carcinoma Neoplasms Carcinoma, Renal Cell Wilms Tumor Rhabdoid Tumor Sarcoma, Clear Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue 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 Dactinomycin Cyclophosphamide Carboplatin Doxorubicin Liposomal doxorubicin Irinotecan Etoposide Vincristine Immunosuppressive Agents |