Ossaal gemetastaseerde maligniteit Bone metastases of a malignant tumor
Conditions
Interventions
Consenting patients will be randomized to receive i.v.
aminobisphosponates plus or minus simvastatin 40 mg once daily.
Simvastatin will be started one week prior to the first administration
of aminobi
Sponsors
Prof. dr. H.M.W. Verheul, MD, PhD
Head Department of Medical Oncology
VU University Medical Center
De Boelelaan 1117
1081 HV Amsterdam
The Netherlands
Tel: +31 (0)20-4444321/300
Fax: + 31 (0)20-4444079
Email: h.verheul@vumc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with an indication for intravenous treatment with an aminobisphosphonate because of bone metastases of a malignant tumor; 2. WHO 0, 1, 2 performance score.
Exclusion criteria
Exclusion criteria: 1. WHO 3, 4 performance score; 2. Prior or current use of aminobisphosphonates; 3. Immunosuppressive medication (NSAID allowed); 4. Chemotherapy and/or radiotherapy in 4 weeks prior to start of aminobisphosphonate administration; 5. Renal insufficiency (creatinin clearance 1.5 times ULN (upper limit of normal); B. ASAT or ALAT > 2.5 times ULN (in absence of livermetastases); C. ASAT or ALAT > 5 times ULN (in presence of livermetastases); D. Concomitant use of strong inhibitors of CYP3A4, such as itraconazol, ketoconazol, erytromycin, claritromycin, hiv; E. Protease inhibitors or grapefruit juice is contra-indicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Phenotypic (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7) and functional (IFN-ã, TNF-á, granzyme B) changes in the circulating pool of Vy9Vd2-T cells; 2. Occurrence of a febrile response. | — |
Contacts
Public ContactJ.J. Vliet, van der
De Boelelaan 1117
Outcome results
None listed