A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

S
Sandeep Batra, MD

Primary Investigator

Administratively Closed
1 years - 30 years
All
Phase N/A
2 Locations

Brief description of study

What is the purpose of this study?
The purpose of this study is to look at iobenguane I-131 or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: neuroblastoma,ganglioneuroblastoma,Childhood Ganglioneuroblastom, Rileya,Childhood Neuroblastoma,Recurrent Neuroblastoma
  • Age: 1 years - 30 years
  • Gender: All

Inclusion Criteria
Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531
Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
No known contraindication to peripheral blood stem cell (PBSC) collection
Exclusion Criteria
Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)
Patients with bone marrow failure syndromes
Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential - Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Additional Information:

Participants will not be paid for their participation.
 

Updated on 05 Dec 2024. Study ID: PHO-COG-ANBL1531

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Connect with the Study Team