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

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00004006
Collaborator
National Cancer Institute (NCI) (NIH)
4
Enrollment
1
Location
94
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Primary Purpose:
Treatment
Official Title:
Treatment for Extrachoroidal or Metastatic Retinoblastoma
Study Start Date :
Nov 1, 1997
Actual Primary Completion Date :
Sep 1, 2005
Actual Study Completion Date :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105-2794

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004006
    Other Study ID Numbers:
    • CDR0000067217
    • P30CA021765
    • SJCRH: RET4
    • NCI-G99-1555
    First Posted:
    Jul 18, 2003
    Last Update Posted:
    Oct 4, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by , ,
    intraocular retinoblastoma
    extraocular retinoblastoma
    recurrent retinoblastoma
    Additional relevant MeSH terms:
    Retinoblastoma
    Cyclophosphamide
    Carboplatin
    Doxorubicin
    Liposomal doxorubicin
    Etoposide
    Topotecan

    Study Results

    No Results Posted as of Oct 4, 2011