Effect of Aminobiphosphonates and Statins on Circulating Vgamma9Vdelta2-T Cells

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 inhibited by simultaneous treatment with statins.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin

Criteria

Inclusion Criteria:

• Patients with an indication for intravenous treatment with an aminobiphosphonate because of a malignant tumor

• WHO 0,1,2 performance score

Exclusion Criteria:

• 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.