Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells

• Conditions: patients with malignant bone metastases; MedDRA version: 12.1Level: LLTClassification code 10005993Term: Bone metastases

• Registration Number: EUCTR2010-018491-24-NL
• Lead Sponsor: Vrije Universiteit Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study (in patients who have an indication for treatment with an intravenous aminobisphosponate because of bone metastases of a malignant tumor) the effects of aminobisphophonate treatment on the phenotype and function on circulating Vy9Vd2-T cells and to determine whether these effects are inhibited by simultaneous treatment with statins.;Secondary Objective: none;Primary end point(s): 1. Phenotypic (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7)and functional (IFN-?, TNF-a, granzyme B) changes in the circulating pool of Vy9Vd2-T cells.<br>2. Occurrence of a febrile response.