Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | Any |
Updated: | 8/16/2018 |
Start Date: | April 16, 2014 |
End Date: | June 30, 2017 |
A Multi-institutional Feasibility Study of Intra-arterial Chemotherapy Given in the Ophthalmic Artery of Children With Retinoblastoma
This pilot clinical trial studies whether unilateral group D retinoblastoma, or
retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can
be treated with a new technique for delivering chemotherapy directly into the blood vessel
that supplies the affected eye. This new technique is called intra-arterial injection. Giving
melphalan via intra-arterial injection may make it less likely that children will need
surgery to remove the eye and may reduce the amount of treatment side effects.
retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can
be treated with a new technique for delivering chemotherapy directly into the blood vessel
that supplies the affected eye. This new technique is called intra-arterial injection. Giving
melphalan via intra-arterial injection may make it less likely that children will need
surgery to remove the eye and may reduce the amount of treatment side effects.
PRIMARY OBJECTIVES:
I. To study the feasibility of delivering melphalan directly into the ophthalmic artery in
children with newly diagnosed unilateral group D retinoblastoma, who would otherwise be
considered for enucleation.
SECONDARY OBJECTIVES:
I. To estimate the ocular salvage rate after treatment with intra-arterial melphalan in
children with newly diagnosed unilateral retinoblastoma with group D disease.
II. To evaluate the toxicities and adverse events associated with delivering multiple doses
of intra-arterial chemotherapy.
III. To evaluate vision outcomes in children treated with intra-arterial chemotherapy.
IV. To monitor the rate of the development of metastatic disease while on protocol therapy.
TERTIARY OBJECTIVES:
I. To evaluate the effects of intra-arterial therapy on the histopathology of eyes enucleated
for progression.
OUTLINE:
Patients receive melphalan intra-arterially (IA) on day 1. Treatment repeats every 28 days
for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 1 year, every 6 months for 1 year, and then periodically for 2 years.
I. To study the feasibility of delivering melphalan directly into the ophthalmic artery in
children with newly diagnosed unilateral group D retinoblastoma, who would otherwise be
considered for enucleation.
SECONDARY OBJECTIVES:
I. To estimate the ocular salvage rate after treatment with intra-arterial melphalan in
children with newly diagnosed unilateral retinoblastoma with group D disease.
II. To evaluate the toxicities and adverse events associated with delivering multiple doses
of intra-arterial chemotherapy.
III. To evaluate vision outcomes in children treated with intra-arterial chemotherapy.
IV. To monitor the rate of the development of metastatic disease while on protocol therapy.
TERTIARY OBJECTIVES:
I. To evaluate the effects of intra-arterial therapy on the histopathology of eyes enucleated
for progression.
OUTLINE:
Patients receive melphalan intra-arterially (IA) on day 1. Treatment repeats every 28 days
for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 1 year, every 6 months for 1 year, and then periodically for 2 years.
Inclusion Criteria:
- Newly diagnosed patients with unilateral group D retinoblastoma
- Magnetic resonance imaging (MRI) (or computed tomography [CT] if MRI is not available)
of the brain must be performed within 14 days prior to study entry
- Diagnostic examination under anesthesia (EUA) must be performed within 14 days prior
to study entry
- Rapid central review confirmation of group D disease based on RetCam images from
diagnostic EUA must be obtained before starting treatment
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1 or 2
- Patients must have a life expectancy of >= 8 weeks
- Patients must have adequate renal function, defined as:
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or
- A serum creatinine based on age/gender as follows:
- 1 month to < 6 months: 0.4 mg/dL
- 6 months to < 1 year: 0.5 mg/dL
- 1 to < 2 years: 0.6 mg/dL
- 2 to < 6 years: 0.8 mg/dL
- 6 to < 10 years: 1 mg/dL
- 10 to < 13 years: 1.2 mg/dL
- 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
- >= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
upper limit of normal (ULN) for age
Exclusion Criteria:
- Patients with bilateral disease
- Unilateral retinoblastoma with group A, B, C, or E eyes
- Prior chemotherapy or radiation therapy for this disease (laser and cryotherapy are
allowed and are not considered exclusion criteria)
- Clinical or neuroimaging evidence of extraocular disease or orbital optic nerve
involvement
We found this trial at
12
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: John P. Perentesis, MD
Phone: 513-636-2799
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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4650 Sunset Blvd
Los Angeles, California 90027
Los Angeles, California 90027
(323) 660-2450
Principal Investigator: Leo Mascarenhas, MD MS
Phone: 323-361-4110
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Ann-Marie Leahey, MD
Phone: 215-590-2810
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Carlos Rodriguez-Galindo, MD
Phone: 866-790-4500
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman, MD
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Miami, Florida 33136
Principal Investigator: Julio C. Barredo, MD
Phone: 866-574-5124
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Nina S. Kadan-Lottick, MD MSPH
Phone: 203-785-5702
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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San Francisco, California 94158
Principal Investigator: Katherine K. Matthay, MD
Phone: 877-827-3222
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