Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. Up to 3 groups of 3 participants will be enrolled
in the Phase I portion of the study, and up to 6 participants will be enrolled in Phase II.
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of radium-223 dichloride based on when you join this study. The first group of
participants will receive the lowest dose level. Each new group will receive a higher dose
than the group before it, if no intolerable side effects were seen. This will continue
until the highest tolerable dose of radium-223 dichloride is found.
If you are enrolled in the Phase II portion, you will receive radium-223 dichloride at the
highest dose that was tolerated in the Phase I portion.
Study Drug Administration:
You will receive radium-223 chloride by vein over several minutes on Day 1 of each 4-week
cycle.
You should drink plenty of fluids before each study drug dose.
You and your caregivers will receive spoken and written instructions about safety
precautions after receiving this drug.
Study Visits:
At all study visits, you will be asked about any drugs you may be taking and if you have had
any side effects from them.
On Day 1 of Cycle 2-6:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
Within 1-3 weeks after Cycle 3:
- You will have scans such as a bone scan and CT or MRI scan to check the status of the
disease.
- Blood (about 1 tablespoon) will be drawn for routine tests.
You may have other routine tests done, including a pregnancy test, if the study doctor
thinks it is needed.
Length of Study Drug Dosing:
You may continue taking the study drug for up to 6 cycles. You will no longer be able to
take the study drug if the disease gets worse, if intolerable side effects occur, or if you
are unable to follow study directions.
Your participation in this study will be over once you have completed the end-of-dosing
visit (and follow-up visits if applicable).
End-of-Dosing Visit:
About 30 days after your last study drug dose:
- You will be asked about any drugs you may be taking and if you have had any side
effects from them.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
- You will have scans such as a bone scan and CT or MRI scan to check the status of the
disease.
Follow-Up Visits:
If you are younger than 18 years old, your height and weight will be measured 1 time a year
until you turn 21. These measurements may stop earlier if your height stays about the same
for 2 years in a row.
This is an investigational study. Radium-223 dichloride is not FDA approved or commercially
available. It is currently being used for research purposes only.
Up to 15 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
If at least 2 patients are observed to have a dose-limiting toxicity (DLT), the MTD will have been exceeded and no further patients will be enrolled at this dose level or at any higher dose level. The prior dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). A tentative MTD becomes final when a total of 6 patients are treated with less than 2 showing DLT. Dose-limiting toxicities include all adverse experiences that are related to study medication, and clearly not related to disease progression or intercurrent illness.
3 months
Yes
Vivek Subbiah, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
2012-0952
NCT01833520
October 2013
Name | Location |
---|---|
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |