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Protocol No.
APEC1621SC
Principal Investigator
DeSantes, Kenneth
Phase
N/A
Age Group
Children
Scope
National
Sponsor Type
National
Title
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
Objective
The main purpose of this 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.
There are two steps for participants in this study:Screening:The purpose of screening is to perform tests on tumor tissue to find out what mutations, if any are present in the tumor. To be eligible for screening, patients must have a tumor sample already available for testing, or there must be a way to do a biopsy of there tumor that the doctor feels is safe to biopsy.
The second step is the investigational treatment part of the study. In this step we will see whether there is an investigational (experimental) drug available through the Pediatric MATCH study that targets the mutations (if any) that are found in
patients tumor. If so, the study doctor will tell the patient about the drug and explain the specifics of getting that drug. He or she will explain the potential side effects and benefits of the drug. In some cases, the side effects of these drugs in children might not be known.
The main purpose of this 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.
There are two steps for participants in this study:
Treatment
NA
Description
Screening Pediatric study for MATCH studies
Key Eligibility
Patients must be ≥ 12 months and ≤ 21 years of age
Patients with recurrent or refractory solid tumors (including nonHodgkin lymphomas, histiocytoses [e.g. LCH, JXG, histiocytic sarcoma], and 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 CSF or serum tumor markers including alpha-fetoprotein or betaHCG
Patients must have an 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
Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age).
Applicable Disease Sites
Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus
Status
Open
Participating Institutions
Gundersen Health System; UW Hospital and Clinics