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| Sponsored by: |
The Hospital for Sick Children |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00110110 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cyclosporine together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Cryotherapy kills tumor cells by freezing them. Laser therapy uses light to kill tumor cells. Giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or laser therapy may be an effective treatment for retinoblastoma.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or laser therapy works in treating patients with newly diagnosed retinoblastoma in both eyes.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinoblastoma |
Drug: carboplatin Drug: cyclosporine Drug: etoposide Drug: filgrastim Drug: vincristine sulfate Procedure: cryosurgery Procedure: laser surgery Procedure: neoadjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Multicenter Phase II Study for International Intraocular Retinoblastoma Classification Groups B, C & D Tumors Treated With Carboplatin-Etoposide-Vincristine-Cyclosporine-Focal Therapy Multimodality Protocol (OCRN Multicenter RB 2003) |
| Estimated Enrollment: | 71 |
| Study Start Date: | June 2004 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive high-dose carboplatin IV over 30 minutes on day 1; vincristine IV over 5 minutes and high-dose etoposide IV over 25 minutes on day 2; cyclosporine IV over 1 hour before chemotherapy and then over 2 hours after chemotherapy on days 1 and 2, and filgrastim (G-CSF) subcutaneously once daily beginning on day 3 and continuing until day 16 or until blood counts recover. Treatment repeats every 21 days for a total of 3 courses for patients with Group B disease and a total of 6 courses for patients with Group C or D disease.
Patients undergo eye examination under anesthesia (EUA) at initial staging and then before each course of chemotherapy. Patients with small peripheral tumors in eyes without retinal detachment undergo minimal focal therapy (mainly cryotherapy) during EUA at initial staging and then after chemotherapy courses 1 and 2. At EUA after the third and subsequent courses of chemotherapy, patients with tumors that have sufficiently reduced in size undergo additional cryotherapy or laser therapy. After completion of chemotherapy, patients with any suspicious, active, or reactivated tumor undergo additional cryotherapy and/or laser therapy during EUA approximately every 4-8 weeks (or at longer intervals) for up to 5 years (as needed).
After completion of study chemotherapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2.4 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinical diagnosis of bilateral intraocular retinoblastoma (RB)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Meets 1 of the following auditory criteria:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Caron Strahlendorf, MD, MBBCH, FCP 604-875-3576 cstrahlendorf@cw.bc.ca | |
| Canada, Ontario | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Helen S. L. Chan, MD, BS, FRCPC, FAAP 416-813-5040 hslchan@attglobal.net | |
| Canada, Quebec | |
| Montreal Children's Hospital at McGill University Health Center | Recruiting |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Contact: Anne-Sophie Carret, MD 514-412-4400 ext. 23190 | |
| Study Chair: | Helen S. L. Chan, MD, BS, FRCPC, FAAP | The Hospital for Sick Children |
More Information
| Study ID Numbers: | CDR0000422340, HFSC-OCRN-RB-2003 |
| Study First Received: | May 3, 2005 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00110110 |
| Health Authority: | Unspecified |
|
intraocular retinoblastoma |
|
Retinal Neoplasms Cyclosporine Eye Neoplasms Clotrimazole Miconazole Eye Diseases Tioconazole Vincristine Carboplatin |
Retinoblastoma Cyclosporins Etoposide phosphate Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Etoposide Retinal Diseases Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antifungal Agents Tubulin Modulators Antirheumatic Agents Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Dermatologic Agents |
