Meeting
2018 ASCO Annual Meeting
Phase II trial of irinotecan/temozolomide/dinutuximab/granulocyte macrophage colony stimulating factor (I/T/DIN/GMCSF) in children with relapsed/refractory neuroblastoma (NBL): A report from the Children's Oncology Group (COG).
Authors
Rajen Mody
University of Michigan, Ann Arbor, MI
Rajen Mody , Arlene Naranjo , Alice L. Yu , Emily Hibbitts , Wendy B. London , Barry L. Shulkin , Marguerite T Parisi , Sabah-E-Noor Servaes , Mitchell B Dicciani , Paul M. Sondel , Julia Glade-Bender , Howard Katzenstein , John Maris , Julie R. Park , Rochelle Bagatell
Organizations
University of Michigan, Ann Arbor, MI, Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL, University of California, San Diego, CA, Children's Oncology Group, Gainesville, FL, Dana-Farber Cancer Institute/Boston Children's Hospital, Boston, MA, St. Jude Children's Research Hospital, Memphis, TN, Seattle Children's Hospital, Seattle, WA, Children's Hospital of Philadelphia, Philadelphia, PA, University of Wisconsin, Madison, WI, Columbia University Medical Center, New York, NY, Nemour's Children's Clinics, Jacksonville, FL, The Children's Hospital of Philadelphia, Philadelphia, PA, Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA
Research Funding
NIH
Background: COG ANBL1221 was a randomized Phase II selection design trial for patients (pts) with relapsed/refractory NBL. Randomization was stopped early when I/T/DIN/GMCSF was shown be the optimal combination for further study. In the small cohort assigned to I/T/DIN/GMCSF, the objective response rate was 53%. An expanded cohort was evaluated to more accurately assess response rate and better define the toxicity profile of this combination. Methods: Pts were eligible at first relapse/progression or first designation of refractory disease. Cycles were administered every 21 days. Objective responses were confirmed centrally. Toxicities were graded according to CTCAE v4.0. Results: 53 eligible pts were assigned to I/T/DIN/GMCSF; 17 during the randomized portion, 36 during study expansion. Median age was 5.1 years (range 1.3-15.9), 39 pts (74%) had measurable disease. Fourteen (26%) had MYCN amplified tumors, 20 (38%) had previously undergone high-dose chemotherapy with stem cell rescue, and 14 (26%) had received prior anti-GD2 antibody. 22 (42%) had relapsed disease and 31 (58%) had refractory/progressive disease (PD). Subjects received 378 total cycles (median 6). Of 53 pts assigned to I/T/DIN/GMCSF, 21 experienced objective responses [40%; 95% CI (26, 53)]; 10 PR, 11 CR. Seven had PD, 23 had stable disease. Two did not receive protocol therapy and did not undergo disease evaluations, but were included in the intention-to-treat analysis. Among responders, 4 (19%) had MYCN amplified tumors and 9 (43%) had previously received an anti-GD2 antibody. Of the 51 evaluable for toxicity, 13 (25%) had Grade 3 pain, 8 (16%) had Grade 3 diarrhea, and 4 (8%) had Grade 3 vomiting. Neutropenia (³Grade 3) was observed in 14 (27%), Grade 3 thrombocytopenia in 5 (10%), and Grade 3 fever/infection in 11 (22%). Conclusions: I/T/DIN/GM-CSF showed significant anti-tumor activity in pts with relapsed/refractory NBL. This combination was well-tolerated in a cohort of > 50 pts. Studies of biomarkers that may identify pts most likely to respond to this chemo-immunotherapeutic regimen are in progress. Clinical trial information: NCT01767194
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Details
Session Type
Oral Abstract Session
Session Title
Pediatric Oncology I
Track
Pediatric Oncology
Sub Track
Pediatric Solid Tumors
Clinical Trial Registration Number
NCT01767194
Citation
J Clin Oncol 36, 2018 (suppl; abstr 10508)
DOI
10.1200/JCO.2018.36.15_suppl.10508
Abstract #
10508
Abstract Disclosures
Similar Abstracts
Abstract
2023 ASCO Annual Meeting
Irinotecan and temozolomide combined with dasatinib and rapamycin for patients with relapsed or refractory neuroblastoma: Results of the prospective randomized RIST trial.
First Author: Selim Corbacioglu
Abstract
2022 ASCO Annual Meeting
Naxitamab and granulocyte macrophage colony stimulating factor (GM-CSF) in combination with irinotecan and temozolomide in patients with high-risk neuroblastoma with primary refractory disease or in first relapse: An international, single-arm, multicenter phase 2 trial.
First Author: Godfrey Chi-Fung Chan
Abstract
2023 ASCO Annual Meeting
A randomized, open-label, phase 2 study evaluating abemaciclib in combination with irinotecan and temozolomide in participants with relapsed or refractory Ewing sarcoma.
First Author: Gertjan VAN HAL
Abstract
2023 ASCO Annual Meeting
Two schedules of vincristine, irinotecan and temozolomide (VIT) for patients with relapsed or refractory Ewing sarcoma: A randomized controlled phase 2 trial.
First Author: Jie Xu