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View Clinical Trial (Medical Research Study)
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Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors - NCT00335556-15213 (Clinical Trial 144982)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy144982.aspx
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| City: |
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15213 |
| Conditions: |
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Kidney Cancer |
| Purpose: |
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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.
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| Study summary: |
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OBJECTIVES:
Primary
- Evaluate whether a treatment regimen containing cyclophosphamide, carboplatin, and
etoposide alternating with vincristine, doxorubicin hydrochloride, and cyclophosphamide
(regimen UH-1) improves the event-free and overall survival of patients with diffuse
anaplastic Wilms' tumor (DAWT) as compared to historical controls.
- Evaluate, in a phase II "window" study, the antitumor activity of a combination of
vincristine and protracted-schedule irinotecan hydrochloride in patients with
metastatic DAWT.
- Evaluate whether regimen UH-1 improves the event-free and overall survival of patients
with malignant rhabdoid tumor (MRT) as compared to historical controls.
- Maintain the excellent event-free survival of patients with stage I clear cell sarcoma
of the kidney (CCSK) without the use of abdominal irradiation.
Secondary
- Describe the outcomes of patients with stage I DAWT or stages I-III focal anaplastic
Wilms' tumor (FAWT) treated with vincristine, dactinomycin, doxorubicin hydrochloride,
and flank radiation.
- Describe the outcomes of patients with stage IV FAWT or stage IV CCSK treated with
regimen UH-1.
- Describe event-free and overall survival of children and adolescents with localized
renal cell carcinoma (RCC) (including patients with local lymph node involvement)
treated with surgical resection without adjuvant therapy.
- Describe response rate, event-free survival, and overall survival of patients with
distantly metastatic RCC treated according to institutional preference.
- Correlate histologic and molecular cytogenetic findings with outcome in pediatric RCC.
- Evaluate the frequency of INI1 mutations in renal and extrarenal MRT and correlate the
presence of detectable INI1 mutation with clinical outcome.
- Determine the frequency of TP53 mutations in anaplastic Wilms' tumor and correlate the
presence of detectable TP53 mutation with clinical outcome.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 6 treatment regimens
according to tumor histology, stage of disease, and response to treatment.
- Surgery (renal cell carcinoma [RCC]): Patients with completely resectable stage I-IV
RCC undergo surgical resection. Patients with incompletely resectable stage IV RCC
undergo treatment as per physician's choice.
- Regimen UH-1 (stage II-III or stage IV [with no measurable disease] diffuse anaplastic
Wilms' tumor [DAWT], stage I-II or stage III-IV [with no measurable disease] malignant
rhabdoid tumor [MRT], stage IV focal anaplastic Wilms' tumor [FAWT], or stage IV clear
cell sarcoma of the kidney [CCSK]): Patients receive vincristine IV on day 1 in weeks
1-3, 10-15, 22-24, and 28-30; doxorubicin hydrochloride IV over 15 minutes on days 1
and 2 and cyclophosphamide (CPM1) IV over 1 hour on day 1 in weeks 1, 10, 13, 22, and
28; and cyclophosphamide (at lower doses [CPM5]) IV over 1 hour and etoposide IV over 1
hour on days 1-5 and carboplatin IV over 1 hour on day 1 in weeks 4, 7, 16, 19, and 25.
Patients also receive filgrastim (G-CSF) subcutaneously or IV once daily beginning 24
hours after completion of chemotherapy and continuing until blood counts recover.
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 CCSK receive no further study therapy.
- Irinotecan/vincristine window therapy* (stage IV DAWT with measurable disease at
diagnosis): 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.
NOTE: *Patients who are eligible for but who are unwilling to receive window therapy,
receive therapy on regimen UH-1.
- Regimen UH-2 (DAWT with CR/PR to irinotecan hydrochloride/vincristine window therapy):
Patients receive vincristine on day 1 in weeks 1-3, 10, 11, 16-21, 25, 26, 28-30, and
34-36 and doxorubicin hydrochloride and CPM1 as in regimen UH-1 in weeks 1, 16, 19, 28,
and 34. Patients also receive CPM5, etoposide, and carboplatin as in regimen UH-1 in
weeks 4, 7, 13, 22, and 31 and irinotecan hydrochloride IV over 30 minutes on days 1-5
in weeks 10, 11, 25, and 26. 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.
- Regimen I (stage I-III CCSK): Patients receive vincristine IV on day 1 in weeks 1-3,
5-9, 11-14, 19, and 25; doxorubicin hydrochloride IV over 15 minutes on day 1 and
cyclophosphamide IV over 1 hour on days 1-3 in weeks 1, 7, 13, 19, and 25; and CPM5 and
etoposide as in regimen UH-1 in weeks 4, 10, 16, and 22. 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.
- Regimen DD-4A (stage I DAWT or stages I-III FAWT): Patients receive dactinomycin IV
over 1-5 minutes on day 1 in weeks 1, 7, 13, 19, and 25; vincristine IV on day 1 in
weeks 1-10, 13, 16, 19, 22, and 25; and doxorubicin hydrochloride IV over 15 minutes on
day 1 in weeks 4, 10, 16, and 22. 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.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 3
years.
PROJECTED ACCRUAL: A total of 295 patients will be accrued for this study. |
| Criteria: |
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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
- 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 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 |
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| Study is available at: |
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Children's Hospital of Pittsburgh
Pittsburgh, PA 15213
United States
Primary Contact:
Clinical Trials Office - Children's Hospital of Pittsburgh
Phone: 412-692-5573 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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