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Lay Description

This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.

Category

  • Nervous System
  • Brain & Nervous System
IRB Number
20180274HU
NCT Number
NCT03057626
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 5 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must have been enrolled on COG neuroblastoma biology study ANBL00B1
  • Patient must have been diagnosed with high-risk neuroblastoma per ANBL00B1 definition
  • Patient must have been diagnosed on or after January 1, 2000
  • At least 5 years must have elapsed since diagnosis
  • Patients must have been treated for high-risk neuroblastoma

    • Note: patients may have had any therapy for high-risk neuroblastoma, including second line or non-established therapies (for example in the setting of less than optimal initial response or concerns for high risk of relapse); patients may have received therapy for refractory or relapsed neuroblastoma, or treatment for an SMN; however all cytotoxic anti-neuroblastoma therapy should have been administered >= 2 years of the enrollment date; SMN therapy may be completed or ongoing at the time of enrollment

Exclusion Criteria

  • Patients must not be currently receiving active anti-neuroblastoma cytotoxic chemotherapy
  • Patients must not have received anti-neuroblastoma cytotoxic chemotherapy within the last two years

    • Note: cytotoxic therapies include (but are not limited to) chemotherapy (platinum agents, alkylators, anthracyclines, topoisomerases, vinca alkaloids, other cytotoxic chemotherapy), any kind of transplant, MIBG therapy, and/or radiation therapy
    • Non-cytotoxic (biologic/targeted/differentiating/other) therapies are permitted at the time of enrollment; for example, patients receiving oral differentiating agents, antiangiogenic therapy, immune modulators, holistic therapies, difluoromethylornithine (DMFO), other minimal residual disease (MRD) therapies/relapse-prevention therapies are eligible
  • Patients with current active neuroblastoma relapse are ineligible

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu

Principal Investigator
Anne-Marie Langevin