Trial Search Results

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

This Pediatric MATCH 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. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Biopsy
  • Procedure: Biospecimen Collection
  • Drug: Ensartinib
  • Drug: Erdafitinib
  • Other: Laboratory Biomarker Analysis
  • Drug: Larotrectinib
  • Procedure: Mutation Carrier Screening
  • Drug: Olaparib
  • Drug: Palbociclib
  • Other: Pharmacological Study
  • Drug: PI3K/mTOR Inhibitor LY3023414
  • Drug: Selumetinib Sulfate
  • Drug: Tazemetostat
  • Drug: Ulixertinib
  • Drug: Vemurafenib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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-HCG

   - ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: 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)

   - ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky >= 50% for patients >
   16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic
   deficits in patients with CNS tumors must have been stable for at least 7 days prior
   to study enrollment; patients who are unable to walk because of paralysis, but who are
   up in a wheelchair, will be considered ambulatory for the purpose of assessing the
   performance score

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all
   subprotocol criteria at time of enrollment onto the APEC1621 screening protocol, but
   will need to meet all criteria prior to enrollment on any assigned treatment
   subprotocol; patients must be enrolled onto a subprotocol within 8 weeks (56 days) of
   treatment assignment

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Karnofsky >= 50% for patients > 16 years
   of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic deficits in
   patients with CNS tumors must have been stable for at least 7 days prior to study
   enrollment; patients who are unable to walk because of paralysis, but who are up in a
   wheelchair, will be considered ambulatory for the purpose of assessing the performance
   score

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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

      - Note: The following do not qualify as measurable disease:

         - Malignant fluid collections (e.g., ascites, pleural effusions)

         - Bone marrow infiltration except that detected by MIBG scan for neuroblastoma

         - Lesions only detected by nuclear medicine studies (e.g., bone, gallium or
         positron emission tomography [PET] scans) except as noted for neuroblastoma

         - Elevated tumor markers in plasma or CSF

         - Previously radiated lesions that have not demonstrated clear progression
         post radiation

         - Leptomeningeal lesions that do not meet the measurement requirements for
         Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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

         - Cytotoxic chemotherapy or other anticancer agents known to be
         myelosuppressive: for agents not listed, the duration of this interval must
         be discussed with the study chair and the study-assigned research
         coordinator prior to enrollment

            - >= 21 days after the last dose of cytotoxic or myelosuppressive
            chemotherapy (42 days if prior nitrosourea)

         - Anticancer agents not known to be myelosuppressive (e.g. not associated with
         reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the
         last dose of agent; for agents not listed, the duration of this interval
         must be discussed with the study chair and the study-assigned research
         coordinator prior to enrollment

         - Antibodies: >= 21 days must have elapsed from infusion of last dose of
         antibody, and toxicity related to prior antibody therapy must be recovered
         to grade =< 1

         - Corticosteroids: If used to modify immune adverse events related to prior
         therapy, >= 14 days must have elapsed since last dose of corticosteroid

         - Hematopoietic growth factors: >= 14 days after the last dose of a
         long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth
         factor; for agents that have known adverse events occurring beyond 7 days
         after administration, this period must be extended beyond the time during
         which adverse events are known to occur; the duration of this interval must
         be discussed with the study chair and the study-assigned research
         coordinator

         - Interleukins, interferons and cytokines (other than hematopoietic growth
         factors): >= 21 days after the completion of interleukins, interferon or
         cytokines (other than hematopoietic growth factors)

         - Stem cell infusions (with or without TBI):

            - Allogeneic (non-autologous) bone marrow or stem cell transplant, or any
            stem cell infusion including donor lymphocyte infusion (DLI) or boost
            infusion: >= 84 days after infusion and no evidence of GVHD

            - Autologous stem cell infusion including boost infusion: >= 42 days

         - Cellular therapy: >= 42 days after the completion of any type of cellular
         therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)

         - X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days
         after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to
         >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM)
         radiation; note: radiation may not be delivered to "measurable disease"
         tumor site(s) being used to follow response to subprotocol treatment

         - Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42
         days after systemically administered radiopharmaceutical therapy

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without
   known bone marrow involvement:

      - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3

      - Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving
      platelet transfusions for at least 7 days prior to enrollment

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Creatinine clearance or radioisotope
   glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on
   age/gender as follows:

      - Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6

      - Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8

      - Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1

      - Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2

      - Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4

      - Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated +
   unconjugated) =< 1.5 x upper limit of normal (ULN) for age

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: serum glutamate pyruvate transaminase
   (SGPT) (alanine transferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN
   for SGPT is 45 U/L)

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact
   capsules/tablets, unless otherwise specified in the subprotocol to which they are
   assigned

   - GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior
   therapy will be included with specific treatment subprotocols

Exclusion Criteria:

   - GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: 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

   - GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: 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

   - GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled
   infection are not eligible

   - GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ
   transplant are not eligible

   - GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will
   be included with specific treatment subprotocols

Ages Eligible for Study

12 Months - 21 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Marcellus
650-723-0567
Recruiting