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