6 studies in Kidney Cancer
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Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms Tumor
Rochester, MN
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Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms Tumor
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (< 2 years of age and < 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk). Secondary - Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker. - Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only. - Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse. - Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2. OUTLINE: This is a multicenter study. Patients are stratified according to clinical and biological risk factors (very low risk vs standard risk). - Stratum I (very low-risk disease): Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks. - Stratum II (standard-risk, stage I or II disease with adverse biological marker): Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV over 15-120 minutes for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks. - Stratum III (standard-risk, stage III disease): Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks. After completion of study treatment, patients are followed periodically for up to 8 years.
NCT ID:
NCT00352534IRB Number:
07-002988Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Study of Kidney Tumors in Young Patients
Rochester, MN
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Study of Kidney Tumors in Young Patients
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. - Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists. Secondary - Monitor outcome for those patients who are not eligible for a subsequent therapeutic study. - Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease. - Describe the sensitivity and specificity of abdominal CT scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver. - Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions. - Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor. OUTLINE: This is a multicenter study. Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and MRIs are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. Patients are followed periodically for 5 years. PROJECTED ACCRUAL: There are no sample size goals for this study.
NCT ID:
NCT00898365IRB Number:
07-000195Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
Rochester, MN
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Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: - To improve 4-year event-free survival to 73% for young patients with bilateral Wilms tumor (BWT) treated with induction chemotherapy, surgery, and postoperative chemotherapy. - To prevent complete removal of at least one kidney in 50% of patients with BWT by using vincristine sulfate, dactinomycin, and doxorubicin hydrochloride as preoperative induction chemotherapy. - To evaluate the efficacy of chemotherapy in preserving renal units and preventing Wilms tumor development in patients with diffuse hyperplastic perilobular nephrogenic rests. - To facilitate partial nephrectomy in lieu of total nephrectomy in 25% of patients with unilateral Wilms tumor and aniridia, Beckwith-Wiedemann syndrome, hemihypertrophy, or other overgrowth syndromes by using vincristine sulfate and dactinomycin as preoperative induction chemotherapy. - To have 75% of patients with BWT undergo definitive surgical treatment by 12 weeks after initiation of preoperative induction chemotherapy. OUTLINE: This is a multicenter study. - Preoperative chemotherapy: Patients receive preoperative chemotherapy according to histology and stage. - VAD regimen (stage I-IV bilateral Wilms tumor [BWT] with biopsy revealing favorable histology or no preoperative biopsy; stage I-III BWT with focal anaplasia; stage I BWT with diffuse anaplasia; or high-risk, stage III-IV unilateral Wilms tumor [WT] with contralateral nephrogenic rest [NR] or predisposition syndrome): Patients receive vincristine sulfate IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6) and dactinomycin IV and doxorubicin hydrochloride IV over 15-120 minutes on days 1 and 22 (weeks 1 and 4). - Revised UH-1 regimen (stage IV BWT with focal anaplasia; stage II-IV BWT with diffuse anaplasia; or stage I-IV malignant rhabdoid tumor of the kidney): Patients receive vincristine sulfate IV on days 1, 8, and 15 (weeks 1-3); doxorubicin hydrochloride IV over 15-120 minutes on day 1 (week 1); cyclophosphamide IV over 1 hour on day 1 and on days 22-25 (weeks 1 and 4); carboplatin IV over 1 hour on day 22 (week 4); and etoposide phosphate IV over 1 hour on days 22-25 (week 4). - EE-4A regimen (high-risk, stage I-II unilateral WT with contralateral NR or predisposition syndrome or diffuse hyperplastic perilobar NRs [DHPLNR]): Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 22, 29, and 36 (weeks 1-6) and dactinomycin IV over 1-5 minutes on days 1 and 22 (weeks 1 and 4). Patients are evaluated at week 6. If partial nephrectomy is feasible, patients proceed to definitive surgery and lymph node sampling followed by postoperative therapy. If partial nephrectomy is not feasible, patients receive additional chemotherapy (as above with the same or a different set of regimen) followed by definitive surgery at week 12 and postoperative therapy OR patients proceed to a different chemotherapy regimen. - Postoperative therapy: Patients receive postoperative therapy according to histology after preoperative chemotherapy and according to the highest assigned risk for either kidney. - EE-4A regimen (BWT with complete resection of all gross tumors at diagnosis with stage I-II favorable histology; BWT with complete response [CR] by imaging after 6 weeks of preoperative chemotherapy; completely necrotic stage I-II BWT; intermediate-risk stage I BWT; unilateral WT stage I-II with CR by imaging after 6-12 weeks of preoperative chemotherapy; completely necrotic stage I-II unilateral WT; or intermediate-risk stage I-II unilateral WT): Patients receive vincristine sulfate IV over 1 minute on days 43, 50, 57, 64, 85, 106, and 127 (weeks 7-10, 13, 16, and 19) and dactinomycin IV over 1-5 minutes on days 43, 64, 85, 106, and 127 (weeks 7, 10, 13, 16, and 19). Patients on EE-4A will NOT receive radiation therapy. - DD-4A regimen (intermediate-risk, stage II BWT; stage I BWT with blastemal predominance; or stage I unilateral WT with blastemal predominance): Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 22, 29, and 36 (weeks 1-6); dactinomycin IV over 1-5 minutes on day 1 (week 1); and doxorubicin hydrochloride IV over 15-120 minutes on day 22 (week 4). Patients then receive vincristine sulfate IV over 1 minute on days 43, 50, 57, 64, 85, 106, 127, 148, and 169 (weeks 7-10, 13, 16, 19, 22, and 25); dactinomycin IV over 1-5 minutes on days 43, 85, 127, and 169 (weeks 7, 13, 19, and 25); and doxorubicin hydrochloride over 15-120 minutes on days 63, 106, and 148 (weeks 10, 16, and 22). Some patients may also undergo radiotherapy. - DD-4A regimen and radiotherapy (BWT with complete resection of all gross tumors at diagnosis with stage III-IV favorable histology, completely necrotic stage III-IV BWT; intermediate-risk, stage III-IV BWT; stage I BWT with diffuse anaplasia; stage I-III BWT with focal anaplasia; stage I unilateral WT with diffuse anaplasia; stage I unilateral WT with focal anaplasia; or intermediate-risk, stage III-IV unilateral WT): Patients receive DD-4A regimen as above. Patients also undergo concurrent radiotherapy. - Regimen I (stage II BWT with blastemal predominance or stage II unilateral WT with blastemal predominance): Patients receive vincristine sulfate IV over 1 minute on days 43, 50, 57, 71, 78, 85, 92, 127, and 169 (weeks 7-9, 11-14, 19, and 25); doxorubicin hydrochloride IV over 15-120 minutes on days 43, 85, 127, and 169 (weeks 7, 13, 19, and 25*); cyclophosphamide IV over 15-30 minutes on days 43, 64, 85, 106, 127, 148, and 169 (weeks 7, 10, 13, 16, 19, 22, and 25); and etoposide phosphate IV over 1 hour on days 64, 106, and 148 (weeks 10, 16, and 22).NOTE: *Omit week 25 doxoubicin dose if patient received 6 or 12 weeks of Regimen VAD. - Regimen I and radiotherapy (stage III-IV BWT with blastemal predominance or stage III-IV unilateral WT with blastemal predominance): Patients receive regimen I as above. Patients also undergo concurrent radiotherapy. - Revised UH-1 regimen and radiotherapy (stage IV BWT with focal anaplasia; stage II-IV BWT with diffuse anaplasia; stage IV unilateral WT with focal anaplasia; and stage II-IV unilateral WT with diffuse anaplasia): Patients receive vincristine sulfate IV over 1 minute on days 64, 71, 78, 85, 92, 99, 148, 155, 162, 190, 197, and 204 (weeks 10-15, 22-24, and 28-30); doxorubicin hydrochloride IV over 15-120 minutes on days 64, 85, 148, and 190 (weeks 10, 13, 22, and 28); cyclophosphamide IV over 15-30 minutes on days 43-46, 64, 85, 106-109, 127-130, 148, 169-172, and 190 (weeks 7, 10, 13, 16, 19, 22, 25, and 28); carboplatin IV over 1 hour on days 43, 106, 127, and 169 (weeks 7, 16, 19, and 25); and etoposide phosphate IV over 1 hour on days 43-46, 106-109, 127-130, and 169-172 (weeks 7, 16, 19, and 25). Patients also undergo radiotherapy. - VAD regimen (DHPLNR with favorable histology WT with viable elements, WT arising in a solitary kidney [patients with metachronous WT are excluded]): Patients receive vincristine sulfate IV over 1 minute on days 43, 50, 57, 64, 71, and 78 (weeks 7-12) and dactinomycin IV over 1-5 minutes and doxorubicin hydrochloride IV over 15-120 minutes on days 43 and 64 (weeks 7 and 10). After completion of study treatment, patients are followed up periodically for 10 years.
NCT ID:
NCT00945009IRB Number:
09-004942Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
Jacksonville, FL
Scottsdale and Phoenix, AZ
Rochester, MN
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Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features. Secondary - To evaluate progression-free survival of these patients. - To evaluate overall survival of these patients. - To describe the toxic effects of both sunitinib malate alone and in combination with gemcitabine hydrochloride in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [clear cell and < 20% sarcomatoid and performance status (PS) 0] vs intermediate risk [20-50% sarcomatoid and PS 0] vs poor risk [non-clear cell or > 50% sarcomatoid or PS 1 or non-clear cell]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. - Arm II: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. In both arms, courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 100 patients (60 in arm I and 40 in arm II) will be accrued to this study.
NCT ID:
NCT01164228IRB Number:
10-006075Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
Rochester, MN
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Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Secondary - To compare the overall survival of patients treated with everolimus vs placebo. - To compare qualitative and quantitative toxicity between the two study arms. - To bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value. - To bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus. OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Archived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.
NCT ID:
NCT01120249IRB Number:
12-010107 -
Bevacizumab With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Kidney Cancer
Rochester, MN
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Bevacizumab With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Kidney Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. To compare the progression-free survival at 12 and 24 weeks for bevacizumab alone or in combination with TRC105 (anti-endoglin monoclonal antibody TRC105). SECONDARY OBJECTIVES: I. Toxicity and Response Evaluation Criteria in Solid Tumors (RECIST) response rate for the combination compared to single agent bevacizumab. TERTIARY OBJECTIVES: I. To evaluate tumor tissue expression of endoglin (CD105), transforming growth factor, beta receptor II (TGFBR2), activin A receptor type II-like 1 (ACVRL1) and transforming growth factor, beta receptor 1 (TGFBR1) kinase from pre- and post-treatment tissue samples in order to determine whether CD105 and stem cell activation occurs after exposure to anti-vascular endothelial growth factor (VEGF) therapy as predicted by laboratory models, and whether exposure to anti-endoglin monoclonal antibody TRC105 affects these changes. II. A primary goal of tissue analysis will be to generate preliminary data to correlate levels of CD105, TGFBR2, ACVRL1 and TGFBR1 in tissue with response to bevacizumab in combination with anti-endoglin monoclonal antibody TRC105 compared to bevacizumab alone. III. To compare the soluble CD105 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with anti-endoglin monoclonal antibody TRC105. IV. To compare TGFBR2 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with anti-endoglin monoclonal antibody TRC105. V. To evaluate whether circulating tumor cells (CTCs) can be detected in this patient population using parylene membrane filter technology, and whether changes in CTC counts and CD105 expression on CTCs during therapy correspond to imaging and clinical response. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15. ARM II: Patients receive bevacizumab as in arm 1 and anti-endoglin monoclonal antibody TRC105 IV over 1-4 hours on days 1, 8, 15, and 22. In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed for 4 weeks.
NCT ID:
NCT01727089Who can I contact for additional information about this study?
Rochester: Charles Erlichman 507-266-3200
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