Research

Neuroblastoma Treatment Using Biology-Based Assessment – Phase III

Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

Protocol Description

This Children’s Oncology Group Phase III study treats neuroblastoma, based on biologic features of the neuroblastoma and its response to chemotherapy, rather than simply providing a standard regimen. Treatment may be stopped when cancer has shrunk by 50 percent. Currently, patients with intermediate-risk neuroblastoma are given 4 or 8 cycles of chemotherapy, with treatment stopped when cancer has shrunk by 90 percent. Researchers believe that in some cases, 2 courses may be sufficient.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders up to age 12, who have a newly diagnosed, intermediate-risk neuroblastoma, ganglioneuroblastoma or ganglioneuroma/maturing subtype.
Males: Up to age 12
Females: Up to age 12

Requirements
Participants will be provided with 2, 21-day initial courses of chemotherapy. Those with a partial response proceed to observation. Those without a partial response will receive 2 to 6 additional courses of chemotherapy. Patients who do not show a partial response will proceed to retrieval chemotherapy, consisting of up to 6 additional 21-day courses. Some patients may undergo suergy.
Visits: 1 to 3 per cycle
Duration: 6 to 42 weeks

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ANBL0531)
National Cancer Institute

Additional Information
Study Description at National Institutes of Health