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Overview
Status |
Active not recruiting |
Phase |
Phase 1 |
Sponsor |
Mohammed Milhem |
Start date |
July 2017 |
End date |
July 2024 |
Enrollment |
17 participants |
Identifiers |
NCT03173976, 201610743 |
Conditions
Chondrosarcoma
Treatments
Zoledronic Acid
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.
Locations
University of Iowa Hospitals and Clinics |
Iowa City, Iowa |
|
Inclusion criteria
1. Male or female patients aged >/= 18 years old
2. ECOG Performance Status of = 2
3. 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
4. Patients must meet the following laboratory criteria:
1. Hematology:
» Neutrophil count of >1500/mm
» Platelet count of > 100,000/mm3
» Hemoglobin ≥ 9 g/dL
2. Biochemistry:
» AST/SGOT and ALT/SGPT =2.5 x upper limit of normal (ULN) or =5.0 x ULN
if the transaminase elevation is due to disease involvement
» Serum bilirubin = 1.5 x ULN; for subjects with Gilbert's syndrome, direct
bilirubin =1.5×ULN and indirect bilirubin =3×ULN
» 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)
» Total serum calcium (corrected for serum albumin) >/= 8.5 mg/dL or ionized
calcium >/= 3.8 mg/dL
» Serum potassium >/= LLN
» Serum sodium >/= LLN
» Serum albumin >/= 3g/dl
5. 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.
6. Patients with biopsy proven dedifferentiated chondrosarcoma that chose not to pursue
neoadjuvant chemotherapy are allowed.
7. Patients must not have received zoledronic acid (ZA) for any reason prior to the
study.
8. Patients with metastatic disease are allowed, if indication to remove primary tumor.
Exclusion criteria
1. Prior use of Osteoclast inhibitors for osteoporosis within 6 months from screening
will not be allowed.
2. Impaired cardiac function
3. Uncontrolled hypertension
4. Creatinine >1.5 or history of Renal disease preventing use of ZA.
5. Other concurrent severe and/or uncontrolled medical conditions including need for
urgent dentoalveolar surgery as indicated by preventative dental exam
6. Concomitant use of any anti-cancer therapy or radiation therapy
7. 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).