to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
- Conditions
- Tumors
- Interventions
- Radiation: 188Re-BMEDA-liposome
- Registration Number
- NCT02271516
- Lead Sponsor
- National Atomic Research Institute, Taiwan
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 188Re-BMEDA-liposome 188Re-BMEDA-liposome 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) 1. 0.42±0.04 mCi/kg 2. 0.63±0.06 mCi/kg 3. 0.84±0.08 mCi/kg 4. 1.05±0.11 mCi/kg 5. 1.26±0.13 mCi/kg 6. 1.47±0.15 mCi/kg
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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
Trial Locations
- Locations (1)
Taipei Veterans General Hospital (Taiwain)
🇨🇳Taipei, Taiwan