Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

Diphosphonates

Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Zometa

Francisco Robert, M.D.

The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma

The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.

Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.

Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.

Novartis Pharmaceuticals

University of Alabama at Birmingham

Professor

Subjects with either stable disease or objective response continued treatment until disease progression and/or intolerable toxicity at which patients were taken off study. Subjects were monitored for toxicity using NCI CTAE v3.0 Criteria. Dose adjustment was allowed per standard guidelines for zoledronic acid for decreased creatinine clearance. Patients who completed at least one treatment cycle were included in data analysis.

Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.

Zoledronic Acid (Zometa)

Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Francisco Robert, MD

Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Participants with advanced malignant pleural mesothelioma.

Tumor Response Rate Following Zoledronic Acid (Zometa)

Progression Free Survival (PFS)

Overall Survival (OS)

Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)	NCT01204203	Mesothelioma	Zometa	19 Years -	University of Alabama at Birmingham
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)	NCT01204203	Mesothelioma	Zometa	19 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for bisphosphonate therapy