Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATION188Re-BMEDA-liposome
EKG at baseline and in 24hours after administration
Sponsors
National Atomic Research Institute, Taiwan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with histologically confirmed diagnosis of primary solid tumor, and with pathologically or radiologically documented metastases * Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors) * Patient with metastatic cancer that are refractory to current standard/available therapies
Exclusion criteria
* brain metastases * serious concurrent infection or nonmalignant illness that is uncontrolled * uncontrolled intercurrent illness * Immunocompromised * significant traumatic injury within 3 weeks before Day 0 * History of hypersensitivity to any component of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the MTD | up to 30 days per cohort | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in vital signs and pysical examination | from day 0 to up t0 60 days per cohort | assess the safety issue from the change in vital signs (BP, PR, RR and temperature) and physical examinations |
| change in lab data | from day 0 to up t0 60 days per cohort | assess the safety issue from the change in lab data including heatology lab data change, Biochemistry laboratory data change and urinalysis data change |
| Adverse event(s) | from day 0 to up t0 60 days per cohort | assessed by NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 |
| Serious Adverse event(s) | from day 0 to up t0 60 days per cohort | 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. |
| Change in EKG | in 24hrs | 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 |
Countries
Taiwan
Outcome results
None listed