Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Recruitment status was Recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of High Risk Renal Tumors |
- Event-free and overall survival [ Designated as safety issue: No ]
- Antitumor activity [ Designated as safety issue: No ]
- 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 |
|---|---|
|
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
|
|
Experimental: Regimen 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: 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
|
|
Experimental: Irinotecan/vincristine window therapy
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
|
|
Experimental: Regimen 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: carboplatin
Given IV
Drug: irinotecan hydrochloride
Given IV
Procedure: conventional surgery
Patients undergo resection
Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week
|
|
Experimental: 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: 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
|
|
Experimental: 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.
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Show 174 Study Locations| 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:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00335556 History of Changes |
| Other Study ID Numbers: | CDR0000472893, COG-AREN0321 |
| Study First Received: | June 8, 2006 |
| Last Updated: | April 2, 2011 |
| 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:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Dactinomycin Doxorubicin Etoposide phosphate |
Irinotecan Cyclophosphamide Etoposide Vincristine Carboplatin Camptothecin 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 May 19, 2013