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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Tumors
• Intervention / Treatment: Radiation: 188Re-BMEDA-liposome

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital (Taiwain)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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); 0.42±0.04 mCi/kg; 0.63±0.06 mCi/kg; 0.84±0.08 mCi/kg; 1.05±0.11 mCi/kg; 1.26±0.13 mCi/kg; 1.47±0.15 mCi/kg	Radiation: 188Re-BMEDA-liposome; EKG at baseline and in 24hours after administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institute of Nuclear Energy Research, Taiwan
• Investigators: Principal Investigator: Shyh-Jen Wang, MD, Taipei Veterans General Hospital (Taiwain)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 22, 2014

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: QCR12009