High dose rate radiation treatment for skin melanoma metastases
A Phase I, First-in-human, Dose Finding Study of High Dose Rate Radiotherapy in Patients With Skin Metastases From Melanoma
This study is testing a new high dose radiation treatment called FLASH therapy to see if it can help patients with skin melanoma that hasn't improved with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lausanne, Vaud) |
| Trial ID | NCT04986696 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of FLASH therapy, a novel high dose rate radiotherapy, for patients with skin metastases from melanoma that have progressed despite systemic treatments. The study involves a dose escalation approach, where single doses of FLASH therapy are administered to assess safety and efficacy. The trial is conducted at a single center, focusing on patients with specific eligibility criteria, including the size and location of the melanoma lesions. The goal is to determine if this new treatment can provide better outcomes for patients with radio-resistant melanoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic melanoma and multiple skin metastases that have shown clinical progression despite prior systemic treatments.
Not a fit: Patients who have previously received radiotherapy in the treated area or have certain autoimmune conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced melanoma that is resistant to conventional therapies.
How similar studies have performed: While FLASH therapy is a novel approach, preliminary studies suggest it may be more tolerable and effective than traditional radiotherapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed study Informed Consent Form 2. Karnofsky Performance Status (KPS) ≥ 50 3. Age ≥ 18 years 4. 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) 5. The size of the treated lesions should be ≤ 5.5 cm in diameter and ≤ 2.8 cm thick (caliper-based measurement) 6. The treated lesions should be at least 5 cm apart and must not be located on the face. 7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (urine or serum) during screening 8. WOCBP must use a contraceptive method Exclusion Criteria: 1. Previous radiotherapy in the treated area 2. Concomitant auto-immune disease with skin lesions 3. Concomitant use of radio-sensitizer drug 4. Women who are pregnant 5. 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. 6. Any serious underlying medical condition that could interfere with study treatment and potential adverse events 7. Any mental or other impairment that may compromise compliance with the requirements of the study
Where this trial is running
Lausanne, Vaud
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jean Bourhis, MD, PhD — Centre Hospitalier Universitaire Vaudois
- Study coordinator: Lana Kandalaft, Pharm D, PhD
- Email: lana.kandalaft@chuv.ch
- Phone: +41 21 314 78 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.