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| Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004006 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Retinoblastoma |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: topotecan hydrochloride Procedure: autologous bone marrow transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment for Extrachoroidal or Metastatic Retinoblastoma |
| Estimated Enrollment: | 10 |
| Study Start Date: | November 1997 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | up to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Study Chair: | Carlos Rodriguez-Galindo, MD | St. Jude Children's Research Hospital |
More Information
| Study ID Numbers: | CDR0000067217, SJCRH-RET-4, NCI-G99-1555 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004006 History of Changes |
| Health Authority: | United States: Federal Government |
|
intraocular retinoblastoma extraocular retinoblastoma recurrent retinoblastoma |
|
Retinal Neoplasms Immunologic Factors Eye Neoplasms Eye Diseases Carboplatin Cyclophosphamide Retinoblastoma Immunosuppressive Agents Etoposide phosphate Recurrence Doxorubicin |
Anti-Bacterial Agents Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Topotecan Alkylating Agents Etoposide Retinal Diseases Neoplasms, Glandular and Epithelial |
|
Retinal Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Retinoblastoma Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Retinal Diseases Neoplasms by Histologic Type |
Eye Neoplasms Eye Diseases Enzyme Inhibitors Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Topotecan Antirheumatic Agents Neoplasms, Glandular and Epithelial |
