Trial Summary
What is the purpose of this trial?
The purpose of this single arm open label phase 1b clinical study is to see what effect zoledronic acid has on tumors in patients with resectable any grade chondrosarcoma prior to surgery.
Research Team
Mohammed Milhem, MBBS
Principal Investigator
University of Iowa
Eligibility Criteria
This trial is for adults with any grade of resectable chondrosarcoma. Participants must have adequate blood counts, liver and kidney function, and not have used osteoclast inhibitors recently. Pregnant or breastfeeding women are excluded, as well as those with severe medical conditions or needing urgent dental surgery.Inclusion Criteria
- Neutrophil count of >1500/mm
Written informed consent from subject or the subject's legally authorized representative, obtained prior to participation in the study and any related procedures being performed
I am 18 years old or older.
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Exclusion Criteria
I have not used osteoclast inhibitors for osteoporosis in the last 6 months.
My heart does not function properly.
I have kidney issues that prevent me from using ZA.
See 4 more
Treatment Details
Interventions
- Zoledronic Acid (Anti-osteoclast Agent)
Trial OverviewThe study tests the effects of Zoledronic Acid on tumors in patients with chondrosarcoma before they undergo surgery. It's a phase 1b single-arm open-label trial, meaning all participants receive the same treatment without a comparison group.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Zoledronic AcidExperimental Treatment1 Intervention
1 cycle of Zoledronic Acid (ZA) at 4mg IVP prior to surgery and a second cycle of ZA at 4 mg IVP 3 weeks after surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mohammed Milhem
Lead Sponsor
Trials
9
Recruited
240+
Varun Monga, MD
Lead Sponsor
Trials
7
Recruited
130+
Rising Tide Foundation
Collaborator
Trials
17
Recruited
6,200+