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Clinical Trial Name - Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients

 
Original Study ID : CDR0000355721
Secondary ID : COG-ARET0331
NCT ID : NCT00079417
Brief Title : Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Official Title : Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
Brief Summary :

RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma. PURPOSE: This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma.

Source : National Cancer Institute (NCI)
Detailed Description :

OBJECTIVES: Primary - Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy. Secondary - Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients. - Correlate response rate with event-free survival in patients treated with this regimen. - Determine the incidence of toxic effects in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106. Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months until 10 years of age, and then annually thereafter. PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study within 3.5 years.

Overall Status : Recruiting
Start Date : December 2005
Official Title : Phase 3
Phase : Interventional
Study Design : Treatment, Open Label
Enrollment : 85
Verification Date : May 2009
First Received Date : March 8, 2004
Trial Eligibility
Criteria :
DISEASE CHARACTERISTICS:

- Newly diagnosed Group B intraocular retinoblastoma meeting 1 of the following
criteria:

- Group B tumor(s) in 1 eye

- Group B tumor(s) in both eyes

- Group A tumor in 1 eye and Group B tumor(s) in the other eye

- Group E tumor in 1 eye that has been enucleated and Group B tumor(s) in the
remaining eye at the time of enucleation of the Group E tumor

- Defined by the International Classification System for Intraocular Retinoblastoma as
follows:

- Group A: Small tumors (≤ 3 mm in greatest dimension) confined to the retina, away
from foveola and disc meeting the following criteria:

- More than 3 mm from fovea

- More than 1.5 mm from optic disk

- Group B: Tumors more than 3 mm meeting the following criteria:

- Confined to the retina in any location not in Group A

- Tumor associated subretinal fluid < 3 mm from the tumor margin with no
subretinal seeding

- Group E: Must have ≥ 1 of the following present:

- Tumor touching the lens

- Tumor anterior to anterior vitreous face involving ciliary body or anterior
segment

- Diffuse infiltrating retinoblastoma

- Neovascular glaucoma

- Opaque media from hemorrhage

- Tumor necrosis with aseptic orbital cellulites

- Phthisis bulbi

- Confirmation of diagnosis by CT scan or MRI of the brain and orbits AND an
ophthalmologic evaluation under anesthesia within the past 3 weeks

- No choroidal and/or optic nerve invasion past the lamina cribosa

- No evidence of extraocular retinoblastoma clinically or by head and orbital MRI and/or
CT scan

- No tumor present on histological exam at the cut end of the optic nerve for any Group
E eye enucleated before study entry

PATIENT CHARACTERISTICS:

Age

- 5 and under

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

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

- AST or ALT < 2.5 times ULN for age

Renal

- Creatinine clearance (based on Schwartz formula) or radioisotope glomerular filtration
rate ≥ 70mL/min/1.73 m^2

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

- No other concurrent radiotherapy, including intensity-modulated stereotactic, or
proton beam radiotherapy

Surgery

- Prior enucleation of one eye allowed provided the remaining eye is Group B

- No concurrent enucleation

Other

- No prior local ophthalmic therapy for retinoblastoma

- No other prior therapy for retinoblastoma

- No local therapy during chemotherapy course 1
Gender : Both
Minimum Age : N/A
Maximum Age : 5 Years
Healthy Volunteers : No
Facilities
Facility Name : Childrens Hospital Los Angeles
Status : Recruiting
City : Los Angeles
State : California
Zip Code : 90027
Country : United States
Facility Name : UCSF Helen Diller Family Comprehensive Cancer Center
Status : Recruiting
City : San Francisco
State : California
Zip Code : 94115
Country : United States
Facility Name : University of Miami Sylvester Comprehensive Cancer Center - Miami
Status : Recruiting
City : Miami
State : Florida
Zip Code : 33136
Country : United States
Facility Name : Winship Cancer Institute of Emory University
Status : Recruiting
City : Atlanta
State : Georgia
Zip Code : 30322
Country : United States
Facility Name : Children's Memorial Hospital - Chicago
Status : Recruiting
City : Chicago
State : Illinois
Zip Code : 60614
Country : United States
Facility Name : University of Illinois Cancer Center
Status : Recruiting
City : Chicago
State : Illinois
Zip Code : 60612-7243
Country : United States
Facility Name : Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Status : Recruiting
City : Boston
State : Massachusetts
Zip Code : 02115
Country : United States
Facility Name : Massachusetts General Hospital
Status : Recruiting
City : Boston
State : Massachusetts
Zip Code : 02114
Country : United States
Facility Name : Barbara Ann Karmanos Cancer Institute
Status : Recruiting
City : Detroit
State : Michigan
Zip Code : 48201-1379
Country : United States
Facility Name : Duke Comprehensive Cancer Center
Status : Recruiting
City : Durham
State : North Carolina
Zip Code : 27710
Country : United States
Facility Name : Cincinnati Children's Hospital Medical Center
Status : Recruiting
City : Cincinnati
State : Ohio
Zip Code : 45229-3039
Country : United States
Facility Name : Children's Hospital of Philadelphia
Status : Recruiting
City : Philadelphia
State : Pennsylvania
Zip Code : 19104-9786
Country : United States
Facility Name : Baylor University Medical Center - Houston
Status : Recruiting
City : Houston
State : Texas
Zip Code : 77030-2399
Country : United States
Facility Name : M. D. Anderson Cancer Center at University of Texas
Status : Recruiting
City : Houston
State : Texas
Zip Code : 77030-4009
Country : United States
Facility Name : Children's Hospital and Regional Medical Center - Seattle
Status : Recruiting
City : Seattle
State : Washington
Zip Code : 98105
Country : United States
OutComes
Primary OutComes
Measure : Event-free survival at 2 years
Safety issue : No
Secondary OutComes
Measure : Use of nonprotocol chemotherapy at the patient level
Safety issue : No
Measure : Enucleation and external beam radiotherapy (EBRT) at the patient and eye levels
Safety issue : No
Measure : Response rate at patient and eye levels after the first course
Safety issue : No
Measure : Event-free survival rate
Safety issue : No
Measure : Toxicity
Safety issue : Yes
Interventions
Type : Drug
Name : carboplatin
Type : Drug
Name : vincristine sulfate
Type : Procedure
Name : cryosurgery
Type : Procedure
Name : laser therapy
Type : Procedure
Name : neoadjuvant therapy
Type : Radiation
Name : iodine I 125
Type : Radiation
Name : ruthenium Ru 106
 
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