Pediatric MATCH Master and Screening Protocol

What is the Purpose of this Study?

This study focuses on pediatric patients who have cancer that has become worse following treatment, or standard therapy does not exist for their type of cancer. The purpose of the study is to learn how well tumors that have specific genetic changes (mutations) respond to drugs that “target” those changes. This combination of a tumor with a mutation and a drug that aims at that mutation is called a “match.” Participants in the screening part of the study will give permission to have the results of a tumor mutation test (already performed by their care team) submitted for review. The results show which of their tumor’s mutations might be targeted by study drugs and will determine whether they will be offered the option of participating in Step 2 of the study (treatment). If the tumor has a mutation targeted by one or more of the investigational drugs used in the study, the patient will be assigned to the study treatment that uses that drug.


Eligibility

  • * ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be \>= 12 months and =\< 21 years of age at the time of study enrollment
  • * ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis \[LCH\], juvenile xanthogranuloma \[JXG\], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); in cases where patient enrolls prior to histologic confirmation of recurrent disease, patient is ineligible and should be withdrawn from study if histology fails to confirm recurrence; please note: Patients with Hodgkin lymphoma and plexiform neurofibroma are not eligible
  • * ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor Testing Requirement: Tumor sample availability requirement for stage 1 of Pediatric MATCH (patients enrolled from start of study in July 2017 through 12/31/21); Patients must have an 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 that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center

More about this Clinical Trial

What is the full name of this clinical trial?

APEC1621MASTER-APEC1621SC: NCI-COG Pediatric MATCH Master and Screening Protocol ^

Study Details
Disease Type/Condition

Bones and Joints, Brain and Nervous System, Ill-Defined Sites, Kidney, Non-Hodgkin's Lymphoma, Soft Tissue

Principal Investigator

Mascarenhas, Leo

Co-Investigators

Fataneh Majlessipour, Nicole Baca

Age Group

Both

Phase

II

IRB Number

Pro00057413

ClinicalTrials.gov ID

NCT03155620

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Bones and Joints, Brain and Nervous System, Ill-Defined Sites, Kidney, Non-Hodgkin's Lymphoma, Soft Tissue

Principal Investigator

Mascarenhas, Leo

Age Group

Both

Phase

II

IRB Number

APEC1621MASTER-APEC1621SC

ClinicalTrials.gov ID

NCT03155620

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org