Chemotherapy in Treating Patients With Retinoblastoma

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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