262 studies in Cancer
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Genetic Epidemiology Of Lung Cancer
Rochester, MN
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Genetic Epidemiology Of Lung Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
The purpose of the study is to compare any inherited or genetic characteristics using blood or tissue specimens collected from individuals who have been diagnosed with lung cancer with the blood or tissue of their family members. The research study is funded by the National Cancer Institute and is part of a national research study being conducted by the Genetic Epidemiology of Lung Cancer Consortium (GELCC).
IRB Number:
07-007338Who can I contact for additional information about this study?
Mariza de Andrade, Ph.D. Principal Investigator Phone: (507) 284-1032 Email: mandrade@mayo.edu
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Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Jacksonville, FL
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Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Location:
Jacksonville, FLTrial status:
Open for EnrollmentWhy is this study being done?
The overall goal of this study is to test a technique that in the future may allow endoscopic detection of pancreatic neoplasia. The study is a single group, prospective, open label pilot study designed to assess the feasibility and efficacy of 4D-ELF in detecting EIBS in peri-ampullary duodenal mucosa in pancreatic cancer patients compared to control patients. The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up is complete after the initial evaluation.
NCT ID:
NCT01015820IRB Number:
09-002596 -
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
Rochester, MN
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Compare the event-free and overall survival of patients with tumor of the Ewing's family treated with standard induction chemotherapy comprising vincristine, dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC) transplantation with or without radiotherapy and/or surgery. Secondary - Determine the prognostic significance of EWS-Flil transcript in these patients. - Determine the frequency and prognostic value of minimal disease in bone marrow and PBSC, as determined by the presence or absence of EWS-Flil transcript, in these patients. - Determine the feasibility and toxicity of VIDE induction chemotherapy in these patients. - Determine the response of these patients to VIDE induction chemotherapy. - Determine the feasibility and toxicity of VAI consolodation chemotherapy in these patients. - Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these patients. - Determine event-free survival and overall survival of patients treated with these regimens by prognostic group analysis. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and local treatment of the primary tumor (yes vs no). Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV over 3 hours, doxorubicin IV over 4 hours, and etoposide IV over 1 hour on days 1-3 (VIDE). Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity. Peripheral blood stem cells (PBSC) are collected after course 3 and/or 4. Patients are evaluated after course 4. Patients in need of early radiotherapy due to an axial tumor or patients who require radiotherapy to the brain and/or spinal cord (at any time during study) are assigned to group 1. Patients not needing early radiotherapy are assigned to group 2. - Group 1: Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy. - Group 2: Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients are randomized to 1 of 2 consolidation therapy arms. - Arm I: Patients receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days. - Arm II: Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks. Patients are followed every 3 months for 4 years, every 6 months for 1 year, and then periodically thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within approximately 7 years.
NCT ID:
NCT00020566IRB Number:
1757-03Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
Rochester, MN
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Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. Determine if monoclonal antibody Chl4.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. SECONDARY OBJECTIVES: I. Determine if monoclonal antibody Chl4.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves overall survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. II. Determine if immunotherapy + RA improves event free survival and overall survival as compared to RA alone, in the subgroup of high risk INSS Stage 4 neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. III. In the subgroup of neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR, determine if there is a difference between the two randomized regimens in reducing the minimal residual disease (MRD) burden as detected by the following parameters: meta-iodobenylguanidine (MIBG) scan, immunocytology (IC) of blood and bone marrow samples, RT-PCR for tyrosine hydroxylase, PGP 9.5, and MAGE-1 in blood and bone marrow. IV. Determine if change from baseline of MRD as measured by above parameters is associated with event free and overall survival V. Determine whether tumor biology at diagnosis correlates with event-free and overall survival, for either of the randomized regimens. VI. Determine the toxicities of the combination of monoclonal antibody Ch14.18 with cytokines. VII. To explore the relationship between antibody-dependent cellular cytoxicity (ADCC) and EFS. VIII. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy. IX. To compare the outcome data of the patients with persistent disease documented by biopsy (Stratum 07) to the historical data for the analogous patients from CCG-3981. X. To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity. XI. To further describe and refine the EFS and OS estimates and baseline characteristics for subjects receiving Chl4.18 + cytokines + RA, following cessation of the randomized portion of the study. XII. To further describe the safety and toxicity of Chl4.18 + cytokines + RA under the new administration guidelines implemented following cessation of the randomized portion of the study with focus on: a) number of courses delivered per subject; b) number of dose reductions or stoppage (ch14.18 and/or IL-2); and c) number of toxic deaths. XIII. To determine the potential effect of ch14.18 on cardiac repolarization and to evaluate ch14.18 plasma levels. XIV. To determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions and blood levels of ch14.18. XV. To determine if the genotype of FcR and Kir/Kir-Ligand correlate with EFS. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to pre-autologous stem cell transplantation (ASCT) response (complete vs very good partial vs partial), stem cells received (purged vs unpurged), and frontline chemotherapy (COG-A3973 vs POG 9341/9342 vs COG-ANGL02P1 vs other therapy). A further stratum consists of patients with biopsy-confirmed post-ASCT persistent disease who are also enrolled on COG-A3973 or COG-ANBL0532. These patients are not randomized but assigned to treatment arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms. ARM I: Beginning on day 67 post-ASCT, patients receive oral isotretinoin twice daily for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy. ARM II: Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral isotretinoin as in arm I beginning on and day 11 of immunotherapy. Patients are followed periodically for 10 years.
NCT ID:
NCT00026312IRB Number:
2093-05Who can I contact for additional information about this study?
Rochester: Carola A. Arndt 507-538-7623
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Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
Rochester, MN
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Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: - Identify surrogate markers of response to neoadjuvant chemotherapy by contrast-enhanced magnetic resonance imaging (MRI) that are predictive of pathologic remissions and survival in women with stage III breast cancer. - Identify two groups of patients who have statistically different 3-year disease-free survival using MRI measurements of tumor response to neoadjuvant chemotherapy. - Determine whether MRI measurements of tumor response after the first course of neoadjuvant chemotherapy can predict which of these patients will ultimately have poor clinical response to chemotherapy. - Compare the accuracy of MRI vs mammography in predicting the extent of residual disease as determined by histopathology in these patients. - Determine whether initial MRI tumor characteristics (morphologic and vascular patterns) predict pathological response and/or survival in these patients. - Estimate the conditional probability of response to paclitaxel based on MRI measurements of response to doxorubicin and cyclophosphamide in these patients. OUTLINE: This is a multicenter study. Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) and magnetic resonance spectroscopy of the breast within 4 weeks before beginning neoadjuvant chemotherapy, 20-28 hours or 48-96 hours after the first course of doxorubicin and cyclophosphamide (Type 1 chemotherapy), between Type 1 chemotherapy and paclitaxel chemotherapy regimens (Type 2 chemotherapy) (MRI only) if the patient continues to Type 2 chemotherapy, and 3-4 weeks after final neoadjuvant chemotherapy treatment (1-2 weeks before surgery). Patients also undergo mammograms and possibly ultrasounds that coincide with the first and last MRI. Core or needle biopsy is performed after the first MRI but before the first course of Type 1 chemotherapy and between Type 1 chemotherapy and Type 2 chemotherapy (if the patient continues to Type 2 chemotherapy). Patients are followed every 6 months for 7-10 years. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.
NCT ID:
NCT00043017Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - Mayo Clinic Cancer Research Consortiu 507-538-7623
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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Jacksonville, FL
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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Location:
Jacksonville, FL Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES:
- Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
- Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
- Compare morbidity and quality of life of patients treated with these regimens.
- Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
- Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
- Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.
After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.NCT ID:
NCT00063882IRB Number:
58-04Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Study of Late-Occurring Complications in Childhood Cancer Survivors
Rochester, MN
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Study of Late-Occurring Complications in Childhood Cancer Survivors
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: - Identify key late-occurring complications, specifically, cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasm, in childhood cancer survivors. - Correlate key late-occurring complications with pathology and staging of the primary malignancy and therapeutic treatment protocol details in these patients. - Identify treatment-related and demographic risk factors by comparing patients who develop late-occurring complications (case group) vs those with the same primary malignancy who do not develop late-occurring complications (control group). - Compare the frequency of mutations or polymorphisms in specific candidate genes in both the case and control groups using constitutional DNA and RNA from both groups. - Explore the role and nature of gene-environment interaction in the development of late-occurring complications in these patients. OUTLINE: This is a multicenter study. DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications, such as cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms. Patients also complete a questionnaire detailing family history and health history. PROJECTED ACCRUAL: A total of 6,900 patients (1,725 with late-occurring complications [case group] and 5,175 without late-occurring complications [control group] [myocardial infarction patients closed to accrual as of 6/5/06, avascular necrosis patients closed to accrual as of 11/26/08, cardiac dysfunction patients closed to accrual as of 4/17/09]) will be accrued for this study.
NCT ID:
NCT00082745IRB Number:
21-05Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Rochester, MN
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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
Location:
Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
OBJECTIVES: Primary - Compare event-free and overall survival of pediatric patients (3 to 7 years of age) with newly diagnosed standard-risk medulloblastoma treated with standard-dose vs reduced-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide. - Compare event-free and overall survival of these patients (8 to 21 years of age) treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen. Secondary - Compare patterns of failure in patients treated with these regimens. - Compare the cognitive, auditory, and endocrinologic effects of these regimens in these patients. - Compare the audiologic and endocrinologic toxicity from these regimens in these patients. - Develop an optimal gene expression medulloblastoma outcome predictor. - Assess quality of life and functional status in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients will undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). Patients receive vincristine IV on days 8, 15, 22, 29, 36, and 43 (weeks 1-6) beginning 31 days after surgery.Patients 3 to 7 years of age are randomized to 1 of 2 chemoradiotherapy arms. Patients 8-21 years old are assigned to arm II. - Chemoradiotherapy:Patients will undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). Patients receive vincristine IV on days 8, 15, 22, 29, 36, and 43 (weeks 1-6) beginning 31 days after surgery. Patients 3 to 7 years of age are randomized to 1 of 2 radiotherapy arms (arms I and II). Patients 8-21 years old are assigned to arm II. - Radiotherapy (first randomization): - Arm I: Patients undergo reduced-dose craniospinal radiotherapy with boost. - Arm II: Patients undergo standard-dose craniospinal radiotherapy with boost. All patients are then randomized to 1 of 2 chemoradiotherapy arms (arms III and IV). - Radiotherapy boost (second randomization): - Arm III: Patients will undergo radiotherapy boost to the entire posterior fossa. - Arm IV: Patients will undergo radiotherapy boost to the tumor bed only. - Maintenance chemotherapy: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration. - Regimen A (courses 1, 2, 4, 5, 7, and 8): Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49. - Regimen B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
NCT ID:
NCT00085735IRB Number:
1617-04Who can I contact for additional information about this study?
Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
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Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery
Scottsdale and Phoenix, AZ
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Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery
Location:
Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MNTrial status:
Open for EnrollmentWhy is this study being done?
PRIMARY OBJECTIVES: I. Compare overall survival of patients with completely resected stage IB (tumors ≥ 4cm)-IIIA non-small cell lung cancer treated with adjuvant chemotherapy with or without bevacizumab. SECONDARY OBJECTIVES: I. Compare disease-free survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients. III. Perform analyses of tissue and blood to establish factors that predict clinical outcome in patients treated with these regimens. IV. Determine whether smoking status is linked to outcome in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs cisplatin/docetaxel vs cisplatin/gemcitabine hydrochloride vs cisplatin/pemetrexed disodium), stage (IB vs II vs IIIA [N2] vs IIIA [T3, N1]), histology (squamous cell vs other), and gender. Patients are randomized to 1 of 2 treatment arms. ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens. REGIMEN 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration. REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration. REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration. REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration. In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Patients complete smoking status questionnaires at baseline and then every 3 months during study treatment. After completion of study treatment, patients are followed periodically for 10 years.
NCT ID:
NCT00324805IRB Number:
07-005703Who can I contact for additional information about this study?
Rochester: Julian R. Molina 507-538-7623
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Scottsdale: Julian R. Molina 507-538-7623
Jacksonville: Julian R. Molina 507-538-7623
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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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