Full Title
DT2216 in Combination with Irinotecan for Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors: A Phase I Study with Phase II Feasibility Cohort for Fibrolamellar Carcinoma (PEPN2411) (CIRB/JIT)Purpose
Researchers are assessing the best dose and benefit of DT2216 given with irinotecan chemotherapy in young people with cancer. DT2216 may help to kill cancer cells by blocking Bcl-xL, a protein that some cancers need to survive. Irinotecan is an anti-cancer drug that is part of the usual treatment for many cancers. Both drugs are given intravenously (by vein).
There are two parts to this clinical trial. In the first part (phase 1), patients with solid tumors that came back or keep growing after treatment will receive a standard dose of irinotecan. They will also get DT2216 at doses that can vary between patients, based on how well they tolerate this combination.
In phase 2, patients with fibrolamellar carcinoma that came back or keeps growing after treatment will receive irinotecan and DT2216. They will get these drugs at the recommended dose as determined in phase 1 of the study.
Who Can Join
To join this study, there are a few conditions. You or your child must:
- Have recovered from the serious side effects of prior therapies before getting the study treatment.
- Phase 1: Be age 1-21 years and have a solid tumor that keeps growing or came back after treatment.
- Phase 2: Be age 1-39 and have fibrolamellar carcinoma that keeps growing or came back after treatment.
Contact
For more information or to see if you or your child can join this study, please call 833-MSK-KIDS.