Active — Not RecruitingPhase 1

Anti-Osteoclast Therapy as Neoadjuvant in Treatment of Chondrosarcoma - Phase 1b Trial

United States17 participantsStarted 2017-07-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients aged \>/= 18 years old
✓. ECOG Performance Status of \</= 2
✓. 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
✓. Patients must meet the following laboratory criteria:
✓. Hematology:
✓. Biochemistry:
✓. Any patient with a biopsy proven diagnosis of chondrosarcoma that is grade I, II or III or in cases where histological and radiological correlation suggests low grade chondrosarcoma as per multidisciplinary discussion.
✓. Patients with biopsy proven dedifferentiated chondrosarcoma that chose not to pursue neoadjuvant chemotherapy are allowed.

Exclusion criteria

✕. Prior use of Osteoclast inhibitors for osteoporosis within 6 months from screening will not be allowed.
✕. Impaired cardiac function
✕. Uncontrolled hypertension
✕. Creatinine \>1.5 or history of Renal disease preventing use of ZA.
✕. Other concurrent severe and/or uncontrolled medical conditions including need for urgent dentoalveolar surgery as indicated by preventative dental exam
✕. Concomitant use of any anti-cancer therapy or radiation therapy
✕. Women who are pregnant or breast feeding or WOCBP not willing to use a double barrier method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).

What they're measuring

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

Timeframe: All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) up to 4 weeks post Cycle 2

Expansion cohort: Response Rate - Change at evaluations

Timeframe: Changes on 2 consecutive evaluations at screening phase (days 1-14); Cycle 2 at 3 weeks post operatively; EOT visit at 4 weeks post Cycle 2; and then at follow up visits every 6 months for up to 5 years.

Trial details

NCT IDNCT03173976

SponsorMohammed Milhem

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20

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