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

Korábbi kezelés

• Prior use of Osteoclast inhibitors for osteoporosis within 6 months from screening will not be allowed.
• 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

Más betegség

• Impaired cardiac function
• Uncontrolled hypertension

Laborértékek

• Creatinine \>1.5 or history of Renal disease preventing use of ZA.

Egyéb

• 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).

• 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:
  • Neutrophil count of \>1500/mm
  • Platelet count of \> 100,000/mm3
  • Hemoglobin \&#8805; 9 g/dL
  • 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
• 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.
• Patients must not have received zoledronic acid (ZA) for any reason prior to the study.
• Patients with metastatic disease are allowed, if indication to remove primary tumor.