Clinical Trial: Chemotherapy in Treating Patients With Retinoblastoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Summary:
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.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: November 1, 1999
Date Started: May 1995
Date Completion:
Last Updated: June 26, 2013
Last Verified: June 2013
