131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat

Neuroblastoma Clinical Trial

— N2011-01  

Official title:

NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035137
• Other study ID #: N2011-01
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: February 26, 2021

Study information

• Verified date: May 2022
• Source: New Approaches to Neuroblastoma Therapy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 30 Years

Eligibility

Inclusion Criteria:

• Patients must be > 24 months and < 30 years of age when registered on study.

• Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with > 3 residual lesions on end-induction MIBG scan.

• Patients must have evidence of MIBG uptake into tumor at = one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.

• Patients must have adequate heart, kidney, liver and bone marrow function. Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.

• Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable CD34+ cells/kg available.

Exclusion Criteria:

• They have had previous I-131 MIBG therapy

• They have other medical problems that could get much worse with this treatment.

• They are pregnant or breast feeding.

• They have a history of a venous or arterial thrombosis that was not associated to a central line.

• They have active infections such as hepatitis or fungal infections.

• They have active diarrhea.

• They have had an allogeneic stem cell transplant (received stem cell from someone else)

• They can't cooperate with the special precautions that are needed for this trial.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Radiation:
• 131I-MIBG

Drug:
• Vincristine

• Irinotecan

• Vorinostat

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	C.S Mott Children's Hospital	Ann Arbor	Michigan
United States	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus	Atlanta	Georgia
United States	Children Hospital of Colorado	Aurora	Colorado
United States	Children's Hospital Boston	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Chicago, Comer Children's Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cook Children's Healthcare System	Fort Worth	Texas
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Lucile Salter Packer Children's Hospital	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
New Approaches to Neuroblastoma Therapy Consortium

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Tumor Response After One Course of Therapy	To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.	43-50 days from study day 1
Secondary	Number of Participants With Grade 3 or Greater Non-hematologic Toxicities	Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG	All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months