Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma

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Brief Title

Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma

Official Title

Treatment for Extrachoroidal or Metastatic Retinoblastoma

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs
      and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
      therapy followed by bone marrow transplantation in treating patients who have retinoblastoma.
    

Detailed Description

      OBJECTIVES:

        -  Evaluate the feasibility of sequential therapy with carboplatin, etoposide,
           cyclophosphamide, doxorubicin, topotecan and radiotherapy followed by autologous bone
           marrow transplantation in patients with extrachoroidal or metastatic retinoblastoma.

        -  Assess this treatment regimen in terms of response and toxicity before and after
           autologous bone marrow transplantation in this patient population.

      OUTLINE: Patients receive carboplatin IV on day 1 and etoposide IV over 1 hour daily on days
      1-3 of weeks 0, 6, and 12, plus cyclophosphamide IV or orally daily on days 1-7, doxorubicin
      IV on day 8 and carboplatin IV over 1 hour on day 10 on weeks 3, 9, and 15. Beginning on week
      6, patients receive concurrent radiotherapy 5 days a week over 4-6 weeks. Patients with
      meningeal involvement receive topotecan intrathecally twice weekly for 3 weeks and then
      weekly for 3 weeks before starting radiotherapy. Beginning one day after each treatment
      course, patients receive filgrastim (G-CSF) subcutaneously daily for 10 days.

      Patients undergo bone marrow collection before or after week 6. Following hematologic
      recovery, patients receive several days of high dose chemotherapy consisting of
      cyclophosphamide and topotecan followed by bone marrow reinfusion.

      Patients are followed at 6, 9, and 12 months, and then every 6 months for 4 years.

      PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
    

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

4

Start Date

November 1997

Completion Date

September 2005

Primary Completion Date

September 2005

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Diagnosis of extrachoroidal or metastatic retinoblastoma, confirmed by histology,
             physical examination, or diagnostic imaging

        PATIENT CHARACTERISTICS:

        Age:

          -  15 and under

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Prior chemotherapy for low stage intraocular disease allowed

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy except to eye(s) or orbit(s)

        Surgery:

          -  Not specified
      

Gender

All

Ages

N/A - 15 Years

Accepts Healthy Volunteers

No

Contacts

Carlos Rodriguez-Galindo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00004006

Organization ID

CDR0000067217

Secondary IDs

P30CA021765


Study Sponsor

St. Jude Children's Research Hospital

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Carlos Rodriguez-Galindo, MD, Study Chair, St. Jude Children's Research Hospital


Verification Date

October 2011