Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by University of Alabama at Birmingham
Sponsor:
University of Alabama at Birmingham
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01204203
First received: September 15, 2010
Last updated: February 22, 2015
Last verified: December 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mesothelioma |
Drug: Zometa (zoledronic acid) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma |
Resource links provided by NLM:
Further study details as provided by University of Alabama at Birmingham:
Primary Outcome Measures:
- Evaluation of the tumor response rate following zoledronic acid [ Time Frame: CT and/or PET scans will be performed to measure tumor size approximately every 56 days until there is tumor growth ] [ Designated as safety issue: Yes ]The best objective response from either the modified RECIST (CT scan) or the Metabloic Response (PET scan) efficacy method of evaluation will be used to determine the first evaluation after 2 cycles of treatment. In subsequent evaluations for response, modified RECIST with CT scans will be the only instrument to evaluate the response to therapy.
Secondary Outcome Measures:
- Evaluation of the duration of tumor response [ Time Frame: Assessments approximately every 8 weeks for the patient's life ] [ Designated as safety issue: No ]The patient's medical condition will be followed for the rest of their lives with continued CT scans being performed every 8 weeks to document tumor growth while off of the study medication.
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: infusion of zoledronic acid
Zoledronic acid will be administered 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 (zoledronic acid)
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.
Other Name: Zoledronic acid
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204203
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204203
Contacts
| Contact: Mary L. Jerome, RN | 205-934-5092 | msjerome@uab.edu | |
| Contact: Liz A. Busby, RN, BSN, OCN | 205-934-0337 | busbyrn@uab.edu |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Mary L. Jerome, RN 205-934-5092 msjerome@uab.edu | |
| Contact: Liz A. Busby, RN, BSN, OCN 205-934-0337 busbyrn@uab.edu | |
| Principal Investigator: Francisco Robert, M.D. | |
Sponsors and Collaborators
University of Alabama at Birmingham
Novartis Pharmaceuticals
Investigators
| Principal Investigator: | Francisco Robert, M.D. | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT01204203 History of Changes |
| Other Study ID Numbers: | F090917002 (UAB 0901), UAB 0901 |
| Study First Received: | September 15, 2010 |
| Last Updated: | February 22, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Alabama at Birmingham:
|
mesothelioma zoledronic acid zometa |
bisphosphonate therapy CT scan PET scan |
Additional relevant MeSH terms:
|
Mesothelioma Neoplasms, Mesothelial Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |
Diphosphonates Zoledronic acid Bone Density Conservation Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 02, 2015