Effect of Aminobiphosphonates and Statins on Circulating Vgamma9Vdelta2-T Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

NCT00042965

Kidney Cancer

COMPLETED PHASE2

3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer

NCT00064064

Lung Cancer

COMPLETED PHASE2

Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases

NCT03520231

Urothelial Carcinoma Kidney Cancer Ureter Cancer +1 more

COMPLETED PHASE2

Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies

NCT01242072

Malignancy Cancer Non Small Cell Lung Cancer +5 more

UNKNOWN PHASE1

Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC

NCT00463515

Non-Small-Cell-Lung Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 statin. Patients already receiving statin treatment will continue this treatment, other patients will be asked whether they are willing to be treated with a statin for a maximum of 5 weeks. 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 aminobisphosphonates and continued for a maximum of 5 weeks. In each patient 10 ml peripheral blood will be drawn (t=0, t=24 hr, t=1 week, t=3-4 weeks (prior to the 2nd aminobisphosphonate administration). In addition, patients will be requested to measure their temperature thrice daily during the 2 days following the first aminobisphosponate administration. This, because a relation between the occurrence of a febrile response upon aminobisphosponate administration and an activation and expansion of Vy9Vd2-T cells has been suggested. Peripheral blood mononuclear cells will be isolated from the drawn peripheral blood. Using intra- and extracellular flowcytometry Vy9Vd2-T cells will be characterized phenotypically (APC markers: CD1d, CD40, CD80, CD83, CD86, HLA-DR; activation/memory markers: CD25, CD27, CD45RA, CD45RO, CCR7) and functionally (IFN-γ, TNF-α, granzyme B). In addition, the frequency of CD3+, CD4+, CD8+ T cells, NK cells, B cells, iNKT cells, CD4+CD25+ regulatory T cells, and circulating dendritic cells will be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Metastases of a Malignant Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aminobiphosphonates

Group Type ACTIVE_COMPARATOR

Aminobiphosphonate

Intervention Type DRUG

Patients will receive standard intravenous biphosphonate treatment

Aminobiphosphonates and Statin

Group Type EXPERIMENTAL

Aminobiphosphonate

Intervention Type DRUG

Patients will receive standard intravenous biphosphonate treatment

Simvastatin

Intervention Type DRUG

40 mg once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aminobiphosphonate

Patients will receive standard intravenous biphosphonate treatment

Intervention Type DRUG

Simvastatin

40 mg once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No