Clinical Trial: PLX3397 in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase I/II Trial of PLX3397 in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neuro
Brief Summary:
Background:
- Some people with cancer have solid tumors. Others have refractory leukemia. This doesn t go away after treatment. Researchers want to see if a drug called PLX3397 can shrink tumors or stop them from growing.
Objectives:
- To find the highest safe dose and side effects of PLX3397. To see if it helps treat certain types of cancer.
Eligibility:
- People ages 3 22 with a solid tumor or leukemia that has returned or not responded to cancer therapies.
- For Phase II, people ages 3 31 with a Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibroma (PN) that cannot be removed with surgery.
Design:
- Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Heart tests
- Scans or other tests of the tumor
- Participants will take PLX3397 as a capsule once daily for a 28-day cycle. They can do this for up to 2 years.
- During the study, participants will have many tests and procedures. They include repeats of the screening tests. Participants will keep a diary of symptoms.
- Participants with solid tumors will have scans or x-rays.
- Participants with NF1 PN will have MRI scans.
- Participants with leukemia
