PLX3397 in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN)
Recruiting
National Cancer Institute (NCI)
Phase 1/Phase 2
2015-04-29
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 will have blood tests. They may have a bone marrow sample
taken.
- Some participants may have a biopsy.
- When finished taking PLX3397, participants will have follow-up visits. They will repeat
the screening tests and note side effects.
- Phase II will follow the same procedures as Phase I above, but participants will also
fill out questionnaires about their pain and quality of life.
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