Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

Overview

About this study

The purpose of this study is to determine safety and measure biodistribution of  two imaging agents in patients with refractory or metastatic melanoma. This study will use [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) imaging. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

​​​​​​Inclusion Criteria:

  • Ability to understand and willingness to provide informed consent.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged ≥ 18 years.
  • Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent.
  • FDG-PET/CT scan available to serve as baseline; the archived scan date must be within 30 days prior to date of enrollment (date initial ICF signed); images from external facilities are allowed. If no archived FDG-PET/CT scan in window, the baseline scan must be obtained at Screening.
  • Complete blood count with differential, within 14 calendar days prior to enrollment, demonstrating the following:
    • White blood cells (WBC) > 2500/mm^3;
    • Hemoglobin (Hgb) > 9.0 g/dL;
    • Platelets > 60,000/mm^3;
    • Absolute Neutrophil Count (ANC) > 1,250/mm^3
      • If no differential is available in the SOC results for enrollment, a subject may be enrolled without the ANC level. Following enrollment, however, this criterion must be met to proceed in the study.
  • Comprehensive metabolic panel, within 14 calendar days prior to enrollment, demonstrating values within the site’s upper limit of normal (ULN), with the following exceptions:
    • Alanine aminotransferase (ALT) ≤ 3 x ULN;
    • Aspartate aminotransferase (AST) ≤ 3 x ULN;
    • Alkaline phosphatase (ALP) ≤ 2.5 x ULN.
  • Ability to lie flat and still for a minimum of two hours for the SPECT scan.
  • For females of reproductive potential: use of highly effective contraception for at least one month prior to screening, and agreement to use such a method during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
  • Agreement to adhere to Lifestyle Considerations throughout study duration.
  • Documented life expectancy of at least 3 months.
  • Access to most recent biopsy is requested (if tissue is available) at screen or if it is obtained through SOC during an expanded window of acceptability; i.e., throughout entire conduct of study at this site. (An updated consent will be obtained.) If a biopsy is completed as part of routine clinical care prior to IRB closure, the study may request access to this sample for tissue MC1R staining and analysis.

Exclusion Criteria:

  • Active secondary malignancy.
  • Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable.
  • Pregnancy.
  • Lactation.
  • Febrile illness within 48 hours of scheduled imaging procedure.
  • Uncontrolled infection.
  • Treatment with another investigational drug within 30 days prior to enrollment date.
  • Subjects initiating BRAFi drugs between baseline FDG scan and enrollment. Subjects receiving consistent, stable therapy with BRAFi for ≥ 3 months prior to enrollment and who have persistent FDG positive malignant lesions on PET imaging are eligible.
  • eGFR < 50 mL/min/1.73m^2.
  • BMI > 50 kg/m^2.
  • Previous medical history of a condition resulting in anaphylaxis or angioedema.
  • Planned treatment while on study with concomitant investigative agents that do not have disclosed safety profiles in the melanoma population (peer-reviewed publications and investigator’s brochures for phase 2 or 3 trials will be accepted as disclosed safety profiles).

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Geoffrey Johnson, M.D., Ph.D.

Open for enrollment

Contact information:

Kera Delaney CCRP

Delaney.Kera@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20509817

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