Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma

  • STATUS
    Recruiting
  • End date
    Jul 20, 2024
  • participants needed
    36
  • sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
Send
Updated on 22 August 2021
See if I qualify

Summary

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.

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.

Details
Condition Uveal Melanoma
Treatment Ziv-aflibercept, stereotactic body radiation therapy
Clinical Study IdentifierNCT03712904
SponsorSidney Kimmel Cancer Center at Thomas Jefferson University
Last Modified on22 August 2021

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note