Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma
NCT ID: NCT00004006
Last Updated: 2011-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
4 participants
INTERVENTIONAL
1997-11-30
2005-09-30
Brief Summary
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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
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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filgrastim
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
topotecan hydrochloride
autologous bone marrow transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Principal Investigators
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Carlos Rodriguez-Galindo, MD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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SJCRH: RET4
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1555
Identifier Type: -
Identifier Source: secondary_id
CDR0000067217
Identifier Type: -
Identifier Source: org_study_id