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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: |
NCT00073879 |
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Date of registration:
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10/12/2003 |
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Primary sponsor: |
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Public title:
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Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
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Scientific title:
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Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00073879 |
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Study type:
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Interventional |
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Study design:
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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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Uday Popat, 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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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of recurrent or metastatic renal cell carcinoma
- Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2
- Clinically evident and followable disease
- Availability of 1 of the following compatible donors:
- Related HLA-identical or 1-Ag mismatched donor
- Unrelated HLA-A, B, DRB1-matched donor
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Karnofsky 70-100%
Life expectancy
- No concurrent illness that severely limits life expectancy
Hematopoietic
- Not specified
Hepatic
- No episode of hepatitis within the past month
- No evidence of chronic active hepatitis or cirrhosis
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- LVEF at least 40%
- No uncontrolled arrhythmias
- No symptomatic cardiac disease
Pulmonary
- FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
participation
- No active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Age minimum:
N/A
Age maximum:
N/A
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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Biological: alemtuzumab
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Biological: graft-versus-tumor induction therapy
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Drug: cyclophosphamide
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Drug: fludarabine phosphate
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Procedure: allogeneic bone marrow transplantation
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Procedure: peripheral blood stem cell transplantation
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Secondary ID(s)
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BCM-H-8447
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CDR0000328247
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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