Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases
Neoplasm Metastasis
About this trial
This is an interventional other trial for Neoplasm Metastasis focused on measuring Advanced skeletal metastases, Radium-223, Radium-223 dichloride, Alpharadin
Eligibility Criteria
Inclusion Criteria:
- ≥ 30 years of age
- has histologically or cytologically confirmed breast or prostate carcinoma
- presents with bony metastases, confirmed by scintigraphic imaging within the previous 4 weeks
- relapsing with new foci in the skeleton after previous external radiotherapy
- has a life expectancy of at least 8 weeks (study part Ia), 5 months for study part Ib
- good performance status; ECOG (Eastern Cooperative Oncology Group) status 0-2
- has normal bone marrow, hepatic, renal and cardiac functions
- clinical chemical laboratory values are within pre-specified range, measured within 7 days prior to dosing day
- for female patients: post-menopausal, surgically sterile or taking adequate contraceptive precaution
Exclusion Criteria:
- has previously been included in this study. This criterion is applicable for patients that receive a single injection of the study drug, but not for patients to be re-treated, or for those to receive a fractionated dosing regimen (study part Ib).
- has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration. This criterion is applicable for patients that receive a single injection of the study drug and for patients to be re-treated.
- has received any other investigational drug than radium-223 in the 4 weeks before first injection of study drug or is scheduled to receiving one during or in the 8 weeks after the fractionated study drug regimen. This criterion is applicable for patients receiving fractionated dose of the study drug.
- has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study
- has other active, serious, life-threatening disease with a life expectancy of less than 8 weeks
- has any uncontrolled infection
- requires oxygen for pulmonary metastases
- has poor renal function with S-Creatinine >150 mmol/L (males), >100 mmol/L (females)
- has heart insufficiency, Class III or IV NYHA (New York Heart Association)
- is pregnant or lactating
- for female patients: of childbearing potential, and not taking adequate contraceptive measures
Sites / Locations
- The Norwegian Radium Hospital
- University Hospital of North Norway
- Karolinska University Hospital
Arms of the Study
Arm 1
Experimental
Radium-223 dichloride
The study had 2 parts. Part 1a was designed with single injections of Radium-223 given to cohorts of 5 patients for each of 5 pre-defined dose levels. Part 1b was designed to retreat and fractionate the dose of Radium-223 in multiple injections.Based on the revised correction factor by calibration, recalculations verified that the single injection doses administered in the part 1a were : 46, 93, 163, 213 and 250 kBq/kg b.w. Two re-treated patients (dose group 6) received a second dose that resulted in a total dose of 250 kBq/kg b.w. The fractionated doses were 1/5 and ½ of the highest dose in part1b (i.e. 250kBq so 5 x 50 and 2 x 125 kBq/kg b.w. respectively).