Effect of aminobisphosphonates and statins on circulating Vgamma9Vdelta2-T cells

Completed

• Conditions: cancer; tumor; 10027476

• Registration Number: NL-OMON36478
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-patients with an indication for intravenous treatment with an aminobisphosphonate because of bone metastases 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 (creatinin 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 livermetastases)
-ASAT or ALAT > 5 times ULN (in presence of livermetastases)
-concomitant use of strong inhibitors of CYP3A4, such as itraconazol, ketoconazol, erytromycin, claritromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Phenotypic (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR;<br /><br>activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7)and functional<br /><br>(IFN-*, TNF-*, granzyme B) changes in the circulating pool of Vy9Vd2-T cells.<br /><br>2. Occurrence of a febrile response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>