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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
Investigation of Genetic Testing-Directed Treatment for Pediatric Tumors
Recruiting
1 years - 21 years
All
Phase
N/A
1 Location
Brief description of study.
This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival.
Detailed description of study
The purpose of this study is to utilize clinical and biological data to screen for eligibility to phase 2 pathway-targeting specific subprotocols of pathway-targeting agents in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders; to determine the proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs; and to determine the objective response rates (ORR; complete response + partial response) in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders harboring a priori specified genomic alterations treated with pathway-targeting agents.
Participant will not be paid for their participation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Histiocytic Sarcoma,Juvenile Xanthogranuloma,Malignant Glioma
-
Age: 1 years - 21 years
-
Gender: All
Inclusion Criteria
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-HCG
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 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 for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas)
At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned
Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Exclusion Criteria
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
Concomitant medications
Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have had a prior solid organ transplant are not eligible
Additional agent specific criteria will be included with specific treatment subprotocols
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-HCG
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 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 for children with diffuse intrinsic pontine gliomas (DIPG, brainstem gliomas)
At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned
Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Exclusion Criteria
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
Concomitant medications
Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have had a prior solid organ transplant are not eligible
Additional agent specific criteria will be included with specific treatment subprotocols
Updated on
19 Feb 2024.
Study ID: 1709401165 (PHO-PRADHAN-COG-APEC1621)
This study investigates how well treatment directed by genetic testing works in children with certain cancers like solid tumors, non-Hodgkin lymphomas, or histiocytic disorders. These are conditions where cells grow uncontrollably in different parts of the body. The study aims to find out if specific changes in genes can be targeted with certain cancer-fighting drugs.
Participants will undergo genetic testing to identify any gene changes that can be targeted with specific treatments. This involves using data from medical tests to see if the tumors have specific gene alterations that can be treated with pathway-targeting agents. These agents are drugs designed to interfere with the pathways that cancer cells use to grow.
- Who can participate: Children with recurrent or hard-to-treat solid tumors, non-Hodgkin lymphomas, or histiocytic disorders can join. They must have a sample of their tumor available for testing and meet certain health criteria.
- Study details: Participants will have genetic testing to see if their cancer has specific gene changes. They may receive a treatment that targets these changes if eligible. A placebo, which is a substance that looks like the treatment but has no active ingredients, is not used in this study.
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