Trial Outcomes & Findings for Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) (NCT NCT01204203)
NCT ID: NCT01204203
Last Updated: 2017-05-24
Results Overview
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.
COMPLETED
PHASE2
8 participants
Baseline up to 28 months or until progressive disease or death
2017-05-24
Participant Flow
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.
The primary objective of this study was to evaluate the anti-tumor activity of zoledronic acid (Zometa) in subjects with unresectable, advanced Malignant Pleural Mesothelioma (MPM).
Participant milestones
| Measure |
Zoledronic Acid (Zometa)
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.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Baseline characteristics by cohort
| Measure |
Zoledronic Acid (Zometa)
n=8 Participants
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.
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|---|---|
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Age, Continuous
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62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 months or until progressive disease or deathPopulation: Participants with advanced malignant pleural 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.
Outcome measures
| Measure |
Zometa
n=8 Participants
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.
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|---|---|
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Tumor Response Rate Following Zoledronic Acid (Zometa)
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12.5 percentage of responders
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SECONDARY outcome
Timeframe: Baseline up to 28 monthsPopulation: Participants with advanced malignant pleural mesothelioma.
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.
Outcome measures
| Measure |
Zometa
n=8 Participants
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.
|
|---|---|
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Progression Free Survival (PFS)
|
2 Months
Interval 0.5 to 21.0
|
SECONDARY outcome
Timeframe: Baseline up to 28 monthsPopulation: Participants with advanced malignant pleural mesothelioma.
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.
Outcome measures
| Measure |
Zometa
n=8 Participants
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.
|
|---|---|
|
Overall Survival (OS)
|
7 months
Interval 0.8 to 28.0
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Adverse Events
Zoledronic Acid (Zometa)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Francisco Robert, MD
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place