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Zoledronic Acid for Chondrosarcoma

Phase 1

Waitlist Available

Led By Mohammed Milhem, MBBS

Research Sponsored by Mohammed Milhem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status of </= 2

- Serum creatinine </= 1.5 x ULN or estimated creatinine clearance ≥ 50 ml/min by Cockcroft-Gault equation: GFR=(140-age)*(wt in kg)*(0.85 if female)/(72xCr)

Must not have

Impaired cardiac function

Creatinine >1.5 or history of Renal disease preventing use of ZA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of zoledronic acid on tumors in patients with resectable any grade chondrosarcoma.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Zoledronic Acid may cause side effects such as fatigue, nausea, bone pain, fever-like symptoms shortly after infusion (flu-like syndrome), low calcium levels in the blood, and potential kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My kidney function is within the required range.

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I have never taken zoledronic acid before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart does not function properly.

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I have kidney issues that prevent me from using ZA.

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I am not pregnant or breastfeeding and willing to use double contraception if of childbearing potential.

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My high blood pressure is not under control.

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I am not currently using any cancer treatments or undergoing radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all eligible patients that have initiated treatment will be considered evaluable for assessing overall survival up to 5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Expansion cohort: Response Rate - Change at evaluations

Phase 1b cohort: Dose Limiting Toxicity - to examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients

Secondary study objectives

Overall survival

Recurrence (local or metastatic) free survival