A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

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Research

Protocol

RET321: A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

Diseases

Solid Tumor : Extra-occular retinoblastoma

Description

Retinoblastoma is a cancer of the eye. Extra-ocular means that tumor cells have spread outside of the eye. Chemotherapy, surgery and radiation therapy, are some of the types of treatment for retinoblastoma. However, patients with extra-ocular retinoblastoma have not fared well with conventional treatment. There is presently no standard treatment for extra-ocular retinoblastoma

This study looks at how well using a combination of different types of treatment called multimodality therapy works when given to children with extra-ocular retinoblastoma. Multimodality therapy includes stronger chemotherapy (called high-dose chemotherapy) with rescue using patient own stem cells. The stem cells help you recover from the bad effects that the stronger chemotherapy will have on the patient’s bone marrow. Multimodality therapy may also include radiation therapy, depending on how well cancer shrinks or disappears during treatment, and surgery. Even though the drugs used in this protocol, stem cell rescue, surgery, and radiation therapy are not new in the treatment of metastatic retinoblastoma, the way that they are used in this study (described as multi modality therapy) is experimental. The duration of the therapy will be for 7-9 months.

Objectives

This study will find out if this multimodality therapy will cure extra ocular retinoblastoma better than treatments used in the past. The goal is to make the retinoblastoma disappear and not recur.
This study will find out how well the first phase of the study treatment (called induction) makes the tumor shrink or disappear
This study will find out what effects good and/or bad that the multimodality therapy has on people with retinoblastoma.

Eligibility

Patient must be no greater than 10 years of age at study enrollment.
Patient must have a diagnosis of extra-ocular retinoblastoma.
No prior chemotherapy or radiotherapy for the extra-ocular retinoblastoma may have been administered prior to entering this study.
All patients and/or their parents or legal guardians must sign a written informed consent.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Ibrahim Qaddoumi, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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