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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00243009 |
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Date of registration:
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20/10/2005 |
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Primary sponsor: |
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Public title:
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Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery
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Scientific title:
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Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00243009 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Brandon M. Hayes-Lattin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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OHSU Knight Cancer Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:
- Clear cell
- Papillary
- Medullary
- Metastatic disease
- Not amenable to curative surgery
- No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 6 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin < 2 times upper limit of normal (ULN)
- AST or ALT < 4 times ULN
Renal
- Creatinine clearance > 50 mL/min
Cardiovascular
- LVEF > 35%
- No symptomatic congestive heart failure
Pulmonary
- DLCO > 40% of predicted OR
- Total lung capacity or FEV_1 > 30% of predicted
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 30 days since prior biologic therapy
Chemotherapy
- More than 30 days since prior chemotherapy
Radiotherapy
- More than 30 days since prior radiotherapy
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Cancer
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Intervention(s)
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Drug: cyclosporine
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Drug: fludarabine phosphate
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Drug: mycophenolate mofetil
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Procedure: allogeneic bone marrow transplantation
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Procedure: peripheral blood stem cell transplantation
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Radiation: radiation therapy
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Primary Outcome(s)
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Response rate (complete and partial response) at 6 and 12 months after transplantation
[Time Frame: No]
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Secondary Outcome(s)
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Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years
[Time Frame: No]
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Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years
[Time Frame: No]
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Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years
[Time Frame: No]
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Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years
[Time Frame: No]
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Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years
[Time Frame: No]
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Toxicity as measured by CTC AE v 3.0 100 days after transplantation
[Time Frame: Yes]
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Secondary ID(s)
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CDR0000447207
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OHSU-1282
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OHSU-ONC-03077-L
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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