Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma
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.
Drug: vincristine sulfate
Procedure: laser therapy
Procedure: neoadjuvant therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Comparing efficacy of study treatment with historic world data, in terms of increasing the proportion of eyes that remains relapse-free while avoiding external beam radiation and/or enucleation [ Time Frame: 5 year follow-up per patient ] [ Designated as safety issue: No ]
- Toxicity during treatment [ Time Frame: 5 year follow-up per patient ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||November 2020|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|Experimental: Combination Chemotherapy with Cyclosporine and Focal Therapy||Biological: filgrastim Drug: carboplatin Drug: cyclosporine Drug: etoposide Drug: vincristine sulfate Procedure: cryosurgery Procedure: laser therapy Procedure: neoadjuvant therapy|
- Compare the efficacy of neoadjuvant high-dose carboplatin and etoposide, vincristine, and cyclosporine (CSA) followed by ophthalmic focal therapy comprising cryotherapy and/or laser therapy to historical world data of chemotherapy treatment without CSA, in terms of increasing the proportion of eyes that remain relapse free and do not require external beam radiotherapy and/or enucleation, in patients with newly diagnosed Group B, C, or D bilateral intraocular retinoblastoma.
- Determine the toxicity of this regimen in these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110110
|Contact: Helen Chanemail@example.com|
|Canada, British Columbia|
|Children's and Women's Hospital of British Columbia||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Contact: Caron Strahlendorf, MD, MBBCH, FCP 604-875-3576 firstname.lastname@example.org|
|Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Helen S. L. Chan, MD, BS, FRCPC, FAAP 416-813-5040 email@example.com|
|Principal Investigator: Brenda L Gallie, MD|
|Sub-Investigator: Elise Heon, MD|
|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|
|Hospital San Juan de Dios||Recruiting|
|Santiago de Chile, Chile, 8500000|
|Contact: Diego Ossandon, MD 56-2574-2103|
|Sankara Nethralaya Super Specialty Clinic||Recruiting|
|Chennai, India, 600 006|
|Contact: Vikas Khetan, MD 91-44-4205-9780|
|Kandang Kerbau Women's and Children's Hospital||Recruiting|
|Singapore, Singapore, 229899|
|Contact: Ah M. Tan, MD 65-6293-4044|
|Principal Investigator:||Brenda L Gallie, MD||The Hospital for Sick Children|
|Principal Investigator:||Elise Heon, MD||The Hospital for Sick Children|
|Study Chair:||Helen SL Chan, MD, BS||The Hospital for Sick Children|