- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712904
Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
Phase II Randomized Trial of Stereotactic Radiotherapy (SRT) Followed by Intravitreal Aflibercept Injection for Patients With Ocular Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the percentage of patients able to successfully complete their prescribed treatment of radiation and intravitreal ziv-aflibercept (aflibercept) injection (IAI) with an acceptable level of toxicity.
SECONDARY OBJECTIVES:
I. To assess for reduction in the incidence of 2-year rates of radiation maculopathy, radiation papillopathy, functional vision preservation, radiation glaucoma, and to assess 2-year local control and progression-free survival.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Cancer Center at Thomas Jefferson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provide signed and dated informed consent form or have a Legally Authorized Representative (LAR) who can give consent
- Willing to comply with all study procedures and be available for the duration of the study
- Must be a candidate for radiation therapy
- Karnofsky performance status (KPS) >= 60
- Diagnosed with uveal melanoma either clinically or pathologically on biopsy
- Uveal melanoma of one eye only
- Localized uveal melanoma, with no evidence of metastasis
- Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to enrollment
Exclusion Criteria:
- Tumor thickness more than 14 mm as measured by ultrasound
- Active collagen vascular disease
- Any contraindication to intravitreal injections including: elevated intraocular pressure, ocular or periocular infection, active intraocular inflammation, or other determined by treating physician
- Known allergic reactions to components of intravitreal Aflibercept
- Patients with known hypercoagulable syndromes
- Prior radiation to the eye or brain
- Life expectancy less than 6 months
- Blind in both eyes
- Patients unable to receive contrast enhanced brain magnetic resonance imaging (MRI)
- Deaf in both ears
- Patients have hypersensitivity to intravitreal Aflibercept
- Patients is on or within 1 month of systemic anti-VEGF treatment
- Patients who are candidates for brachytherapy
- Patients for whom enucleation is standard of care
Pregnancy or active breastfeeding. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly
- Contraception is not required for men with documented vasectomy
- Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A. Stereotactic body radiation therapy, ziv-aflibercept
Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10.
Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
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Undergo radiation
Other Names:
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Experimental: B. Stereotactic body radiation therapy, ziv-aflibercept
Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
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Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade 3 or higher toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame: Up to 2 years
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Will be determined by patients who experience grade >= 3 toxicity related to stereotactic radiation therapy and/or intravitreal aflibercept.
Will be tested using one-sided exact binomial test with alpha 0.05.
The two arms will be combined for the primary analysis
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation maculopathy rate defined as ophthalmoscopic detection of macular edema perivascular sheathing
Time Frame: At 2 years
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Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.
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At 2 years
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Radiation papillopathy rate defined as ophthalmoscopic detection of peripapillary encircling nerve fiber layer infarction
Time Frame: At 2 years
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Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.
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At 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wenyin Shi, MD, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
- Endothelial Growth Factors
Other Study ID Numbers
- 18P.457
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uveal Melanoma
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedIris Melanoma | Medium/Large Size Posterior Uveal Melanoma | Stage IIA Uveal Melanoma | Stage IIB Uveal Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal MelanomaUnited States
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National Cancer Institute (NCI)ExelisisCompletedStage IV Uveal Melanoma AJCC v7 | Recurrent Uveal Melanoma | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stage IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7United States, Canada
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedStage IV Uveal Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedIris Melanoma | Stage IV Uveal Melanoma | Medium/Large Size Posterior Uveal Melanoma | Recurrent Uveal Melanoma | Ocular Melanoma With Extraocular Extension | Small Size Posterior Uveal MelanomaUnited States, Canada
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Alliance for Clinical Trials in OncologyWithdrawnMetastatic Uveal Melanoma | Advanced Uveal Melanoma | Unresectable Uveal Melanoma
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National Cancer Institute (NCI)CompletedStage IV Cutaneous Melanoma AJCC v6 and v7 | Recurrent Melanoma | Stage IIIC Cutaneous Melanoma AJCC v7 | Mucosal Melanoma | Iris Melanoma | Stage IIIA Cutaneous Melanoma AJCC v7 | Stage IIIB Cutaneous Melanoma AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanoma | Recurrent... and other conditionsUnited States
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National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Active, not recruitingMetastatic Uveal Melanoma | Stage IV Uveal Melanoma AJCC v7United States
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National Cancer Institute (NCI)CompletedStage IV Uveal Melanoma AJCC v7 | Recurrent Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Uveal Melanoma AJCC v7 | Recurrent Uveal MelanomaUnited States, France, United Kingdom
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