Irradiation of Melanoma in a Pulse

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    46
  • sponsor
    Centre Hospitalier Universitaire Vaudois
Updated on 5 September 2021

Summary

This is a single center phase I, first-in-human, dose escalation study of FLASH therapy in patients with metastases of melanoma.

The trial is based on escalating single doses of FLASH therapy administered to skin melanoma metastases using the Mobetron with high dose rate (HDR) functionality.

The aim of the study is to evaluate a dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments. Melanoma is a typically radio-resistant tumor type, which can justify such a dose escalation with a new type of radiotherapy that appears much better tolerated than conventional radiotherapy.

Details
Condition Metastasis From Malignant Melanoma of Skin (Diagnosis)
Treatment FLASH therapy
Clinical Study IdentifierNCT04986696
SponsorCentre Hospitalier Universitaire Vaudois
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed study Informed Consent Form
Karnofsky Performance Status (KPS) 50
Age 18 years
Patients with metastatic melanoma and multiple skin metastases with a documented clinical progression despite the systemic treatments (chemotherapy, and/or Programmed cell death 1 (PD1), cytotoxic T-lymphocyte antigen-4 (CTLA4) inhibitors or tyrosine kinase inhibitors (TKIs), such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF) or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors)
The size of the treated lesions should be 5.5 cm in diameter and 2.8 cm thick (caliper-based measurement)
The treated lesions should be at least 5 cm apart and must not be located on the face
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (urine or serum) during screening
WOCBP must use a contraceptive method

Exclusion Criteria

Previous radiotherapy in the treated area
Concomitant auto-immune disease with skin lesions
Concomitant use of radio-sensitizer drug
Women who are pregnant
Current, recent (within 10 days prior start of study treatment), or planned participation in an experimental drug study. During the 4 weeks DLT period, the patient will not be able to participate to any other clinical study
Any serious underlying medical condition that could interfere with study treatment and potential adverse events
Any mental or other impairment that may compromise compliance with the requirements of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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