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

NCT01204203 | Completed Phase 2 Results DMC

• 2 other identifiers: F090917002 (UAB 0901)UAB 0901
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mesothelioma

Keywords

mesothelioma; zoledronic acid; zometa; bisphosphonate therapy; CT scan; PET scan

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate Following Zoledronic Acid (Zometa)

  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.

  Baseline up to 28 months or until progressive disease or death

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Baseline up to 28 months

• Overall Survival (OS)

  Baseline up to 28 months

Study Arms (1)

Zometa

EXPERIMENTAL

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.

Drug: Zometa

Interventions

Zometa DRUG

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.

Also known as: Zoledronic acid

Zometa

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females \> 18 years of age
• Life expectancy of at least 2 months
• Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
• Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening
• ECOG Performance Status of 0-2
• Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
• ANC ≥ 1.5 x 109/L
• Platelet Count ≥ 100 x 109/L
• Hemoglobin ≥ 9g/dL
• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST ≤ 2.5 x ULN
• ALT ≤ 2.5 x ULN
• ALK-P ≤ 3 x ULN
• Serum creatinine ≤ 1.8mg/dL
• Calculated Serum Creatinine Clearance 40 - \> 60ml/min

You may not qualify if:

• Known central nervous system (CNS) tumor involvement
• Evidence of other active malignancy requiring treatment
• Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)
• Known infection with HIV or hepatitis
• Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.
• Active, serious systemic disease, including active bacterial or fungal infection.
• Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.
• Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.
• Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Francisco Robert, MD
• Organization: University of Alabama at Birmingham

pacorobertuab@cs.com

205-934-5077

Study Officials

• Francisco Robert, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: June 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)