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Some concerns arose for the accumulation of radioactivity in liver and spleen.
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This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.
Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 188Re-BMEDA-liposome | Experimental | Stage I: 188Re-BMEDA-liposomes, 14±1.4 mCi, single dose Stage II: 188Re-BMEDA-liposomes, dose-escalation, single dose Dose Level Dose of 188Re-BMEDA-liposome (mCi/kg)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 188Re-BMEDA-liposome | Radiation | EKG at baseline and in 24hours after administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD | The design will use cohort of 3 patients. If none of the first 3 patients experience DLT, then dose escalation will proceed for the next dose level of patients unless the present dose level is level 6 (1.47±0.15 mCi/kg). | up to 30 days per cohort |
| Measure | Description | Time Frame |
|---|---|---|
| change in vital signs and pysical examination | assess the safety issue from the change in vital signs (BP, PR, RR and temperature) and physical examinations | from day 0 to up t0 60 days per cohort |
| change in lab data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shyh-Jen Wang, MD | Taipei Veterans General Hospital (Taiwain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital (Taiwain) | Taipei | 11217 | Taiwan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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assess the safety issue from the change in lab data including heatology lab data change, Biochemistry laboratory data change and urinalysis data change
| from day 0 to up t0 60 days per cohort |
| Adverse event(s) | assessed by NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 | from day 0 to up t0 60 days per cohort |
| Serious Adverse event(s) | All AE(s) and SAE(s) which occurred within follow-up visit after the single dose administration of study drug should be followed until resolution or the event is considered stable. | from day 0 to up t0 60 days per cohort |
| Change in EKG | Patient will be examined the EKG by standard 12-lead at screen visit for eligibility. After enrollment, patient will be attached on a 24h-portable EKG monitor to monitoring EKG before and post-administration of Stage I and II low dose and therapeutic infusion dose for 24hrs | in 24hrs |