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

NCT ID: NCT02271516

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

188Re-BMEDA-liposome

Intervention Type RADIATION

EKG at baseline and in 24hours after administration

Interventions

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188Re-BMEDA-liposome

EKG at baseline and in 24hours after administration

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Atomic Research Institute, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyh-Jen Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital (Taiwain)

Locations

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Taipei Veterans General Hospital (Taiwain)

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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QCR12009

Identifier Type: -

Identifier Source: org_study_id

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