This study is NOT currently recruiting participants.
Number
18-C-0126
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 1 Years Max Age: 21 Years
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Pregnant Women
Keywords
Molecular Profiling; Mutation; Biomarker; Molecular Targeting
Recruitment Keyword(s)
None
Condition(s)
Advanced Malignant Solid Neoplasm; Non-Hodgkin Lymphoma; Histiocytic Disorder; Cancer
Investigational Drug(s)
Larotrectinib Erdafitinib
Investigational Device(s)
Intervention(s)
Drug: Larotrectinib Drug: Erdafitinib Drug: Tazemetostat Drug: LY3023414 Drug: Selumetinib Drug: Ensartinib Drug: Vemurafenib Drug: Olaparib Drug: Palbociclib
Supporting Site
National Cancer Institute
Usual cancer treatment is chemotherapy, radiation, and/or surgery. But this doesn t always help. Recently, much has been learned about mutations (changes) found in different tumors. Drugs can be developed to target these changes. But only a few have been approved and their effect on pediatric patients is mostly unknown. Researchers want to test cancer tumors of young people. If a mutation is found, the person will be invited to take a drug that targets it.
Objective:
To study how drugs that target specific changes affect tumors with those changes and any side effects.
Eligibility:
People ages 1-21 with cancer that has worsened after treatment or has no standard treatment
Design:
Participants will be screened with a medical history, physical exam, scans, and blood tests and provide a tumor sample.
Researchers will test the tumor and blood for certain mutations.
Participants with the mutations who can swallow tablets whole can join the treatment part of the study for up to 2 years. They will be assigned to get 1 of 8 study drugs. The drugs have been tested in adults but most haven t been tested in children.
Participants will take the study drug 1-2 times each day in 28-day cycles.
Before starting the drug and during the cycles, participants will repeat most screening tests and have a urine test. Some participants may also have:
-Eye exam
-Bone marrow test
-Neurological exam
-Heart tests
-X-ray
Participants will write down when they take the drugs, side effects, and other medicines they take.
Participants should not become pregnant or father a child while on any of the study drugs.
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ELIGIBILITY: - Age >= 12 months and <= 21 years of age at the time of study enrollment. - Patients with recurrent or refractory solid tumors (including non-Hodgkin lymphomas, histiocytoses [e.g. LCH, JXG, histiocytic sarcoma], and CNS tumors) are eligible. - Patients must have a formalin fixed paraffin embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample. NOTE: A tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas).
- Age >= 12 months and <= 21 years of age at the time of study enrollment.
- Patients with recurrent or refractory solid tumors (including non-Hodgkin lymphomas, histiocytoses [e.g. LCH, JXG, histiocytic sarcoma], and CNS tumors) are eligible.
- Patients must have a formalin fixed paraffin embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample. NOTE: A tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas).
Principal Investigator
Referral Contact
For more information: