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

Sponsor

Institute of Nuclear Energy Research, Taiwan (Other)

Overall Status

Terminated

CT.gov ID

NCT02271516

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tumors	Radiation: 188Re-BMEDA-liposome	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital (Taiwain)	Taipei		Taiwan	11217

Sponsors and Collaborators

Institute of Nuclear Energy Research, Taiwan

Investigators

Principal Investigator: Shyh-Jen Wang, MD, Taipei Veterans General Hospital (Taiwain)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Nuclear Energy Research, Taiwan

ClinicalTrials.gov Identifier:

NCT02271516

Other Study ID Numbers:

QCR12009

First Posted:

Oct 22, 2014

Last Update Posted:

Jul 30, 2020

Last Verified:

Jul 1, 2020

Study Results

No Results Posted as of Jul 30, 2020