to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage

Tumors Clinical Trial

Official title:

A Phase I, Open-label, Dose-escalation 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02271516
• Other study ID #: QCR12009
• Status: Terminated
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2020
• Source: Institute of Nuclear Energy Research, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tumors

Intervention

Radiation:
• 188Re-BMEDA-liposome
EKG at baseline and in 24hours after administration

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital (Taiwain)	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Nuclear Energy Research, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	change in lab data	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
Secondary	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
Secondary	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
Secondary	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