Research

Retinoblastoma (Extra-ocular) Multi-modal Treatment – Phase III

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

Protocol Description

This Children’s Oncology Group Phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma, a cancer of the eye that has spread beyond the eye.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, up to age 10, who have a confirmed extraocular retinoblastoma.
Males: Up to age 10
Females: Up to age 10

Requirements
Participants will get 4, 3-4 week cycles of induction chemotherapy, and during that stage blood stem cells will be collected through apheresis. If induction is successful at diminising the tumor, the child will enter the consolidation stage, in which additional chemotherapy will be provided and his/her blood stem cells will be reinfused. Radiation therapy may follow.
Visits: Requires hospitalization
Duration: About 6 to 8 months, with participants followed for about 10 years.

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ARET0321)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health