Status:
COMPLETED
Effect of Aminobiphosphonates and Statins on Circulating Vgamma9Vdelta2-T Cells
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Bone Metastases of a Malignant Tumor
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of aminobiphosphonate treatment on the phenotype and function of circulating Vgamma9Vdelta2-T cells and to determine whether these effects are i...
Detailed Description
A total of 40 patients will be entered in this study. Half of the patients will receive standard intravenous treatment with aminobsiphosphonates, the other half will be additionally be treated with a ...
Eligibility Criteria
Inclusion
- Patients with an indication for intravenous treatment with an aminobiphosphonate because of a malignant tumor
- WHO 0,1,2 performance score
Exclusion
- WHO 3, 4 performance score
- prior or current use of aminobisphosphonates -immunosuppressive medication (NSAID allowed)
- chemotherapy and/or radiotherapy in 4 weeks prior to start of aminobisphosphonate administration
- renal insufficiency (creatinine clearance \< 30 ml/min)
- liver enzyme abnormalities:
- bilirubin \> 1.5 times ULN (upper limit of normal)
- ASAT or ALAT \> 2.5 times ULN (in absence of liver metastases)
- ASAT or ALAT \> 5 times ULN (in presence of liver metastases)
- concomitant use of strong inhibitors of CYP3A4, such as itraconazole, ketoconazole, erytromycin, clarithromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01179464
Start Date
August 1 2010
End Date
May 1 2013
Last Update
June 14 2013
Active Locations (1)
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1
VU University Medical Center
Amsterdam, Netherlands, 1081HV