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

National Atomic Research Institute, Taiwan

Status and phase: Terminated; Phase 1

Conditions: Tumors

Treatments: Radiation: 188Re-BMEDA-liposome

Study type: Interventional

Funder types: Other

Identifiers

NCT02271516

QCR12009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

188Re-BMEDA-liposome

Experimental group

Description:

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

Treatment:

Radiation: 188Re-BMEDA-liposome