Clinical trial NCT00432445: Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
Official title: A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Retinoblastoma
Keywords: Children with retinoblastoma
Retinoblastoma
Pediatrics
Proton Beam Radiation Therapy
Radiation Therapy
Tumor of the Eye
Ophthalmic EUA
Examination under anesthesia
Bilateral retinoblastoma
Unilateral retinoblastoma
Extraocular disease
Intraocular procedure
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-02-07
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention.

Detailed description: External photon beam radiation therapy (which is current standard of care) has been used in the treatment of retinoblastoma. It is a form of radiation therapy in which the radiation is delivered by a machine pointed at the area to be radiated.

Proton beam radiation therapy is a form of external photon beam radiation therapy, but it may be more effective because its adjusted dosing delivers less radiation to surrounding areas of the tumor, which helps preserve other tissues and cause fewer side effects.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your eye doctor will perform an assessment of your eye, including an exam while you are under anesthesia. This exam will include a dilated eye exam, photography of your affected eye (by a Ret-Cam), ultrasound of your affected eye, and imaging scans, such as computed tomography (CT) or magnetic resonance imaging (MRI), if the doctor thinks it is necessary. The assessments will be done to check and confirm the status of the disease.

After diagnosis of retinoblastoma, the study doctor will first see if external photon beam radiation therapy is a reasonable treatment option for you. If external photon beam radiotherapy is deemed appropriate for you, you will be eligible to receive proton beam radiation therapy in this study.

If you are found to be eligible to take part in this study, you will be treated with proton beam radiation therapy. Treatment will begin within 1 week of referral to the M. D. Anderson Proton Center. It will be given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.

Within 2-4 weeks after completion of therapy, you will have an eye exam performed under anesthesia (like the one during screening). You will have repeated eye exams under anesthesia, depending on the appearance and response of the tumor to therapy. This will occur about every 1-4 months.

You will continue to have these eye exams until the tumors are considered to be stable or unless your disease gets worse.

If the disease gets worse or you experience any intolerable side effects, you may be taken off treatment.

You will be required to have lifelong eye and medical assessments to continue to monitor you for disease. If no disease is found 5 years after completion of proton beam radiation therapy, you will be considered free of disease. You will then have annual (yearly) eye and pediatric assessment through adulthood.

This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M.D. Anderson.

Eligibility criteria: Inclusion Criteria:

1. Active or recurrent retinoblastoma patient eligible for treatment of external beam radiation therapy.
2. A parent or guardian who can provide informed consent to a minor or child participant.
3. No concurrent infection.
4. No contraindication for repeated general anesthesia/sedation.

Exclusion Criteria:

1. Inability to return for multiple examinations under anesthesia.
2. Medical contraindication for exams under anesthesia/sedation.
3. Unreliable follow-up.

Primary outcomes:
measure: Rate of Local Control in the Globe at 12 Months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Dan Gombos, MD
role: PRINCIPAL_INVESTIGATOR
References: