A Phase I Stereotactic Radiotherapy dose escalation study with Immune pathway activation for metastatic Melanoma

Phase 1

Completed

• Conditions: Metastatic Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12616001064493
• Lead Sponsor: Alfred Health Radiation Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-09
• Study Completion: 2018-11-26
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

*Aged 18 or older.
*Willing and able to provide informed consent.
*Histologically confirmed metastatic melanoma.
*At least one extra-cranial metastasis that is symptomatic or imminently symptomatic and may impact quality of life or ability to tolerate ongoing treatment.
*Non-oligometastatic disease (defined more than 5 total metastasis, or more than 3 metastasis in any organ system) and
1. At least one extra-cranial metastasis that can be treated with a SABR dose of at least 20Gy (as determined by a Radiation Oncologist).
2. Intracranial disease control (defined as surgery and/or stereotactic radiotherapy to all intracranial sites).
3. At least one extra-cranial metastasis that will not be treated with SABR to monitor response.
*Able to tolerate treatment with Immunotherapy (as determined by a Medical Oncologist).

Exclusion Criteria

*Patient with a life expectancy less than 3 months, including those with malignant pleural or pericardial effusions.
*Patients requiring immediate surgical intervention
1. Clinical or radiologic evidence of spinal cord compression
2. Dominant brain metastasis requiring surgical decompression
*Pregnant or lactating females
*Significant auto-immune diseases including inflammatory bowel disease, rheumatoid arthritis and Systemic Lupus Erythematosus

Study & Design

• Study Type: Interventional
• Study Design: Not specified