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A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy


Phase 3
N/A
6 Years
Not Enrolling
Both
Intraocular Retinoblastoma

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Trial Information

A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy


OBJECTIVES:

I. Prospectively determine the prevalence of high-risk histopathologic features, such as
choroidal involvement, optic nerve invasion, and scleral and anterior segment involvement,
in patients with newly diagnosed unilateral retinoblastoma who have undergone enucleation.

II. Demonstrate that patients without certain high-risk features can be successfully treated
with enucleation alone by estimating the event-free survival (EFS) (where an event is
defined as the occurrence of extraocular or metastatic disease) and overall survival (OS).

III. Estimate the EFS and OS of patients with specific high-risk features who are uniformly
treated with adjuvant chemotherapy comprising vincristine, carboplatin, and etoposide.

IV. Estimate the incidence of toxicities associated with the proposed adjuvant chemotherapy
regimen.

OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are assigned to 1
of 2 groups according to presence of high-risk histopathologic features.

GROUP 1 (high-risk features): Patients receive vincristine IV and carboplatin IV over 1 hour
on day 1 and etoposide IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.

GROUP 2 (no high-risk features): Patients undergo observation periodically for at least 5
years.

After completion of study treatment, patients in group 1 are followed periodically for at
least 5 years.


Inclusion Criteria:



- Newly diagnosed unilateral retinoblastoma

- Underwent enucleation as primary therapy within the past 5 weeks

- Must enroll and submit pathology slides within 21 days of enucleation

- Adjuvant chemotherapy must begin within 35 days after enucleation

- Disease with or without high-risk histopathologic features

- High-risk features are defined as any of the following:

- Posterior uveal invasion (includes choroidal invasion)

- Any degree of concomitant choroid and/or optic nerve involvement

- Tumor involving the optic nerve posterior to the lamina cribrosa as an
independent finding

- Scleral invasion

- Anterior chamber seeding

- Ciliary body infiltration

- Iris infiltration

- No evidence of extraocular retinoblastoma clinically, by CT scan, or by MRI of the
brain and orbits with and without gadolinium

- No tumor at the cut end of the optic nerve on any eye enucleated as evidenced by
histologic examination prior to study entry

- No systemic metastases as evidenced by bone marrow scan, bone scan, or any other
additional test at study entry

- Lansky performance status 50-100%

- Hemoglobin > 8 g/dL

- Absolute neutrophil count ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine adjusted according to age as follows:

- No greater than 0.4 mg/dL (≤ 5 months)

- No greater than 0.5 mg/dL (6 months -11 months)

- No greater than 0.6 mg/dL (1 year-23 months)

- No greater than 0.8 mg/dL (2 years-5 years)

- No greater than 1.0 mg/dL (6 years-9 years)

- No greater than 1.2 mg/dL (10 years-12 years)

- No greater than 1.4 mg/dL (13 years and over [female])

- No greater than 1.5 mg/dL (13 years to 15 years [male])

- No greater than 1.7 mg/dL (16 years and over [male])

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

- AST or ALT < 2.5 times ULN for age

- No prior therapy other than enucleation

- No prior chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival (EFS)

Outcome Description:

EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features (treated with adjuvant chemotherapy) and separately for subjects without high risk features (treated with enucleation alone).

Outcome Time Frame:

At 2 years

Safety Issue:

No

Principal Investigator

Murali Chintagumpala

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

ARET0332

NCT ID:

NCT00335738

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Intraocular Retinoblastoma
  • Retinoblastoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Johns Hopkins UniversityBaltimore, Maryland  21205
Cleveland Clinic FoundationCleveland, Ohio  44195
Mayo ClinicRochester, Minnesota  55905
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Marshfield ClinicMarshfield, Wisconsin  54449
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Scott and White Memorial HospitalTemple, Texas  76508
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Brooklyn Hospital CenterBrooklyn, New York  11201
Covenant Children's HospitalLubbock, Texas  79410
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Lehigh Valley Hospital - MuhlenbergBethlehem, Pennsylvania  18017
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Duke University Medical CenterDurham, North Carolina  27710
Wayne State UniversityDetroit, Michigan  48202
University of Arizona Health Sciences CenterTucson, Arizona  85724
University of KentuckyLexington, Kentucky  40536-0098
M D Anderson Cancer CenterHouston, Texas  77030
Childrens Memorial HospitalChicago, Illinois  60614
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
University of IllinoisChicago, Illinois  60612
Cook Children's Medical CenterFort Worth, Texas  76104
The Children's Medical Center of DaytonDayton, Ohio  45404
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
Children's Oncology GroupArcadia, California  91006-3776
The Childrens Mercy HospitalKansas City, Missouri  64108
Rainbow Babies and Childrens HospitalCleveland, Ohio  44106
Children's Hospital and Medical Center of OmahaOmaha, Nebraska  68114
Childrens Hospital-King's DaughtersNorfolk, Virginia  23507
Children's Hospital ColoradoAurora, Colorado  80045
University of California San Francisco Medical Center-ParnassusSan Francisco, California  94143