A Phase 2 interventional study of Zometa in Mesothelioma, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-05-24.
Sponsored by University of Alabama at Birmingham · Phase 2, Interventional, and Treatment
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.
470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 371 interventional studies indexed under Mesothelioma.
Browse Mesothelioma studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
Exclusion Criteria:
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
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
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.
Time frame: Baseline up to 28 months or until progressive disease or death
Progression Free Survival (PFS)
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.
Time frame: Baseline up to 28 months
Overall Survival (OS)
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.
Time frame: Baseline up to 28 months
Inclusion criteria included: adult patients (age\>18) with unresectable Malignant Pleural Mesothelioma (MPM) who had progressed after one or more prior systemic therapies, had not received prior systemic therapy due to poor performance status (PS), and/or were unwilling to receive systemic chemotherapy.
| Milestone | Zoledronic Acid (Zometa) |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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.
| percentage of responders | Zometa |
|---|---|
| Tumor Response Rate Following Zoledronic Acid (Zometa) | 12.5 |
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.
| Months | Zometa |
|---|---|
| Progression Free Survival (PFS) | 2 (0.5 to 21) |
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.
| months | Zometa |
|---|---|
| Overall Survival (OS) | 7 (0.8 to 28) |
Collected over From baseline to 28 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zoledronic Acid (Zometa) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Zoledronic Acid (Zometa) |
|---|---|
| Median | 62 (49 to 77) |
| Sex: Female, Male(Participants) | Zoledronic Acid (Zometa) |
|---|---|
| Female | 0 |
| Male | 8 |
| Region of Enrollment(participants) | Zoledronic Acid (Zometa) |
|---|---|
| United States | 8 |
Plan to share: No
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University of Alabama at Birmingham