Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
Condition: Breast Cancer; Hypercalcemia of Malignancy; Colon Cancer; Endocrine Cancer; Head and Neck Cancer; Kidney Cancer; Lung Cancer; Lymphoma; Metastatic Cancer; Multiple Myeloma; Parathyroid Neoplasms; Renal Cancer; Thyroid Cancer; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Non-Small Cell Lung Cancer
MeSH terms: Lymphoma; Lung Neoplasms; Multiple Myeloma; Neoplasms; Kidney Neoplasms; Parathyroid Neoplasms; Paraneoplastic Syndromes; Endocrine Gland Neoplasms; Hypercalcemia
Intervention: denosumab
Intervention description: 120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15.
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypercalcemia; calcium; bisphosphonates; denosumab; amgen; malignancy; 20070315; HMC; oncology; hematology

Summary:

      The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia
      of Malignancy in patients with elevated serum calcium who do not respond to recent treatment
      with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9
      millimoles /L) by day 10.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypercalcemia of Malignancy (HCM) as defined as documented histologically or
             cytologically confirmed cancer and a corrected serum calcium (CSC) > 12.5 mg/dL (3.1
             millimoles /L) at screening by local laboratory

          -  Last IV bisphosphonate treatment must be >/= to 7 days and </= to 30 days before the
             screening corrected serum calcium

          -  Adults (>/=18 years)

          -  Adequate organ function as defined by the following criteria:

          -  serum aspartate aminotransferase (AST) </= 5 x upper limit of normal (ULN)

          -  serum alanine aminotransferase (ALT) </= 5 x upper limit of normal

          -  serum total bilirubin </= 2 x upper limit of normal

        Exclusion Criteria:

          -  Evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency,
             vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous
             disease

          -  Receiving dialysis for renal failure

          -  Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their
             window of expected therapeutic effect (as determined by the physician) prior to the
             date of the screening CSC

          -  Treatment with cinacalcet within 4 weeks prior to the date of the screening CSC

          -  Thirty days or less since receiving an investigational product (other than denosumab)
             or device (ie, does not have marketing authorization; thalidomide use is allowed) in
             another clinical study

          -  Known sensitivity to any of the products to be administered during the study (eg,
             mammalian derived products)

          -  Female subject is pregnant or breast feeding, or planning to become pregnant within 7
             months after the end of treatment

          -  Female subject of childbearing potential is not willing to use 2 highly effective
             methods of contraception during treatment and for 7 months after the end of treatment

          -  Subject will not be available for follow-up assessment.

          -  Any organic or psychiatric disorder that, in the opinion of the investigator, might
             prevent the subject from completing the study or interfere with the interpretation of
             the study results