Brief Title
Chemotherapy in Treating Patients With Retinoblastoma
Official Title
A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
patients with retinoblastoma.
Detailed Description
OBJECTIVES: I. Estimate the response rate to adjuvant carboplatin (CBDCA) alone in children
with intraocular retinoblastoma. II. Assess the overall survival, disease-free survival, and
time to treatment failure in these patients. III. Attempt to maintain a 90% disease-free
survival rate with this treatment. IV. Estimate the percentage of disease-free survivors who
do not require the use of radiotherapy after adjuvant CBDCA. V. Assess the toxicity of this
treatment. VI. Estimate the percentage of functional eyes salvaged using this
radiation-sparing protocol and compare these results, in a nonrandomized manner, with
historical treatment results in this population.
OUTLINE: Patients are stratified according to vitreous disease (yes vs no). Patients receive
carboplatin IV over 1 hour on day 0. Treatment repeats every 2-3 weeks for 2 courses.
Patients achieving complete response (CR) proceed to local control measures consisting of
cryotherapy, laser photocoagulation, etc. (except brachytherapy). Patients not achieving CR
continue with carboplatin until local control measures feasible. Patients with vitreous
disease achieving CR receive 2 additional courses and then receive local control measures.
Patients with vitreous disease not achieving CR receive intensive chemotherapy. Patients
receive intensive chemotherapy consisting of vincristine IV on days 0, 7, and 14, cisplatin
IV over 6 hours on day 0, etoposide IV on days 1 and 2, followed by cyclophosphamide IV over
60 minutes on days 1 and 2. Patients receive filgrastim (G-CSF) subcutaneously beginning on
day 3 and until blood counts recover. Treatment repeats every 2-4 weeks for 2 courses beyond
CR. Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-6 years.
Study Phase
Phase 2
Study Type
Interventional
Condition
Retinoblastoma
Intervention
filgrastim
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
50
Start Date
May 1995
Completion Date
January 2001
Primary Completion Date
January 2001
Eligibility Criteria
DISEASE CHARACTERISTICS: Intraocular retinoblastoma Ophthalmologic exam under anesthesia
within 3 weeks prior to registration No pathologic confirmation required No evidence of
extraocular disease, i.e.: Negative head MRI or CT (contrast not required) Negative CSF
cytology Negative bone marrow aspiration and biopsy
PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Hematopoietic: Not
specified Hepatic: Bilirubin less than 2.0 mg/dl SGOT or SGPT less than 5 times upper limit
of normal Renal: Creatinine normal for age OR Creatinine clearance greater than 50 ml/min
PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Gender
All
Ages
N/A - 17 Years
Accepts Healthy Volunteers
No
Contacts
Ira Dunkel, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00002675
Organization ID
95-040
Secondary IDs
CDR0000064317
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Ira Dunkel, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
June 2013