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Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
Phase 2 trial testing Stereotactic Body Radiation Therapy in Uveal Melanoma in 3 participants. Terminated before completion.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 9 August 2019 |
| Primary completion | 20 September 2022 |
| Estimated completion | 23 December 2022 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
18 and older, female only, with Uveal Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept.
| Group | Value | 95% CI |
|---|---|---|
| A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 | |
| B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | 0 |
Time frame: The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | A. Stereotactic Body Radia… | B. Stereotactic Body Radia… |
|---|---|---|---|
| Retinal detachment - Grade 3 | Eye disorders | — | — |
| Death | General disorders | — | — |
| Reaction | System | A. Stereotactic Body Radia… | B. Stereotactic Body Radia… |
|---|---|---|---|
| Blurred Vision - Grade 1 | Eye disorders | — | — |
| Eye Hemorrhage - Grade 2 | Eye disorders | — | — |
| Eye Pain - Grade 1 | Eye disorders | — | — |
| Hypertension - Grade 3 | Vascular disorders | — | — |
| Subretinal Fluid - Grade 1 | Eye disorders | — | — |
| Visual field defect - Grade 1 | Eye disorders | — | — |
| Allergic Rhinitis - Grade 1 | Respiratory, thoracic and mediastinal disorders | — | — |
| Atrial Fibrillation - Grade 3 | Cardiac disorders | — | — |
| Bloating - Grade 1 | General disorders | — | — |
| Cardiac Myopathy - Grade 1 | Cardiac disorders | — | — |
| Cataract - Grade 1 | Eye disorders | — | — |
| Chronic Kidney Disease - Grade 1 | Hepatobiliary disorders | — | — |
| Coronary Artery Disease - Grade 1 | Cardiac disorders | — | — |
| Dyspnea - Grade 1 | Vascular disorders | — | — |
| Episcleritis - eye - Grade 1 | Eye disorders | — | — |
| Erythma - face - Grade 1 | Skin and subcutaneous tissue disorders | — | — |
| Fatigue - Grade 1 | General disorders | — | — |
| Flashing lights - eye - Grade 1 | Eye disorders | — | — |
| Floaters - Eye - Grade 1 | Eye disorders | — | — |
| Focal dissection in right hepatic artery - Grade 1 | Vascular disorders | — | — |
| Foreign body sensation - eye - Grade 1 | Eye disorders | — | — |
| Hearing impairment - Grade 1 | Ear and labyrinth disorders | — | — |
| Hernia - Grade 1 | Musculoskeletal and connective tissue disorders | — | — |
| Hyperglycemia - Grade 1 | Blood and lymphatic system disorders | — | — |
| Impaired fasting glucose - Grade 1 | Metabolism and nutrition disorders | — | — |
| Impaired Hearing - Grade 1 | Ear and labyrinth disorders | — | — |
| Hyperkalemia - Grade 1 | Hepatobiliary disorders | — | — |
| Left Eye Buckle - Grade 1 | Eye disorders | — | — |
| Left eye superior arc worse - Grade 1 | Eye disorders | — | — |
| Microcytic anemia - Grade 1 | Blood and lymphatic system disorders | — | — |
| Myelodysplastic Syndrome - Grade 1 | Cardiac disorders | — | — |
| Nuclear sclerosis - both eyes - Grade 1 | Eye disorders | — | — |
| Osteoarthritis - Grade 1 | Musculoskeletal and connective tissue disorders | — | — |
| Pain - Back - Grade 1 | General disorders | — | — |
| Periorbital changes - Grade 1 | Eye disorders | — | — |
| Peripheral sensory neuropathy - Grade 1 | Musculoskeletal and connective tissue disorders | — | — |
| Photophobia - Grade 1 | Skin and subcutaneous tissue disorders | — | — |
| Redness - Eye - Grade 1 | Eye disorders | — | — |
| Renal insufficiency - Grade 1 | Hepatobiliary disorders | — | — |
| Retinal detachment - Grade 2 | Eye disorders | — | — |
Most-reported serious reactions: Retinal detachment - Grade 3, Death.
Data from ClinicalTrials.gov NCT03712904 adverse events section.
This phase II trial studies how well stereotactic body radiation therapy and aflibercept work in treating patients with uveal melanoma. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving stereotactic body radiation therapy followed by aflibercept may work better in treating patients with uveal melanoma.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03712904.