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A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA


Phase 2
N/A
17 Years
Not Enrolling
Both
Retinoblastoma

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Trial Information

A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ira Dunkel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

95-040

NCT ID:

NCT00002675

Start Date:

May 1995

Completion Date:

January 2001

Related Keywords:

  • Retinoblastoma
  • intraocular retinoblastoma
  • Retinoblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021