Norman J. Lacayo, MD

Associate Professor of Pediatrics (Hematology and Oncology)

Clinical Focus

Hematology/Oncology/Stem Cell Transplant, Pediatric
Oncology (Cancer), Pediatric
AML, childhood and adolescent/young adult
ALL, childhood and adolescent/young adult
lymphoblastic lymphoma, childhood
Pediatric Hematology-Oncology

Academic Appointments

Associate Professor - University Medical Line, Pediatrics - Hematology & Oncology
Member, Maternal & Child Health Research Institute (MCHRI)
Member, Stanford Cancer Institute

Administrative Appointments

Member, Cancer Center (2007 - Present)
Myeloid Steering Committee, Children's Oncology Group (2007 - Present)
Director, Pediatric Oncology Experimental Therapeutics Investigators' Consortium [POETIC] (2019 - Present)

Honors & Awards

Member, Alpha Omega Alpha (1990)
New Approaches in Pediatric Myeloid Leukemia, V Foundation (10/09-09/12)
Banking Acute Leukemia Specimens at Lucile Packard Childrens Hospital: Hyundai Infrastructure Grant, Hyundai Foundation (10/11-09/12)
Molecular and Pharmacologic Correlates of Acute Myeloid Leukemia in Down Syndrome, NIH ROI subcontract from Wayne State University (01/09-04/16)

Professional Education

Board Certification: American Board of Pediatrics, Pediatric Hematology-Oncology (2022)
Medical Education: University of California at San Francisco School of Medicine (1989) CA
Internship: UCSF Medical Center (1990) CA
Residency: UCSF Medical Center (1992) CA
Fellowship: Stanford University Medical Center (1995) CA
MD, U.C., San Francisco, Medicine (1989)
BA, U. C., Berkeley, Biochemistry (1985)

Contact

Academic lacayon@stanford.edu

Clinical (Primary)

This is the primary clinic for this clinical provider. For additional clinical locations and information, please visit the link(s) listed below in the 'Additional Clinical Info' section.

Bass Cancer Center for Childhood Cancer and Blood Diseases 725 Welch Rd MC 5913 Palo Alto CA 94304 Tel: (650) 497-8953 Fax: (650) 497-8959

Additional Clinical Info

Stanford Medicine Children's Health

Current Research and Scholarly Interests

Pediatric Hematology/Oncology, Phase I drug studies for refractory and relapsed leukemia; genomic studies, biologic risk-stratification and treatment of acute myeloid leukemia; prediction or induction response and risk of relapse using phosphoproteomics in childhood AML; novel MRD techniques in childhood ALL.

Clinical Trials

Niclosamide in Pediatric Patients With Relapsed and Refractory AML Recruiting
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Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.

Lead Sponsor
- Stanford University
Stanford Investigators
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Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy Recruiting
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This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study. This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Lead Sponsor
Stanford Investigators
- Tanja A. Gruber
- Norman J. Lacayo, MD
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A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors Recruiting
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This is a Phase I/II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with chemotherapy or venetoclax, in pediatric and young adult participants with acute leukemias or solid tumors. This study is divided into three parts: Part 1 will begin with dose escalation of idasanutlin as a single agent in pediatric participants with relapsed or refractory solid tumors to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and to characterize dose-limiting toxicities (DLTs). Following MTD/MAD identification, three separate safety run-in cohorts in neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) will be conducted to identify the recommended Phase 2 dose (RP2D) of idasanutlin in each combination, with chemotherapy or venetoclax. Part 2 will evaluate the safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult participants in neuroblastoma, AML,and ALL cohorts at idasanutlin RP2D. Part 3 will potentially be conducted as an additional expansion phase of the idasanutlin combination cohorts in neuroblastoma, AML, or ALL for further response and safety assessment.
Lead Sponsor
Stanford Investigators
- Norman J. Lacayo, MD
View full details
Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma Recruiting
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The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.
Lead Sponsor
Stanford Investigators
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Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility Recruiting
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The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.
Lead Sponsor
Stanford Investigators
- Norman J. Lacayo, MD
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Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma Recruiting
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The overarching objective of this study is to use novel precision medicine strategies based on inherited and acquired leukemia-specific genomic features and targeted treatment approaches to improve the cure rate and quality of life of children with acute lymphoblastic leukemia (ALL) and acute lymphoblastic lymphoma (LLy). Primary Therapeutic Objectives: - To improve the event-free survival of provisional standard- or high-risk patients with genetically or immunologically targetable lesions or minimal residual disease (MRD) ≥ 5% at Day 15 or Day 22 or ≥1% at the end of Remission Induction, by the addition of molecular and immunotherapeutic approaches including tyrosine kinase inhibitors or chimeric antigen receptor (CAR) T cell / blinatumomab for refractory B-acute lymphoblastic leukemia (B-ALL) or B-lymphoblastic lymphoma (B-LLy), and the proteasome inhibitor bortezomib for those lacking targetable lesions. - To improve overall treatment outcome of T acute lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LLy) by optimizing pegaspargase and cyclophosphamide treatment and by the addition of new agents in patients with targetable genomic abnormalities (e.g., activated tyrosine kinases or JAK/STAT mutations) or by the addition of bortezomib for those who have a poor early response to treatment but no targetable lesions, and by administering nelarabine to T-ALL and T-LLy patients with leukemia/lymphoma cells in cerebrospinal fluid at diagnosis or MRD ≥0.01% at the end of induction. - To determine in a randomized study design whether the incidence and/or severity of acute vincristine-induced peripheral neuropathy can be reduced by decreasing the dosage of vincristine in patients with the high-risk CEP72 TT genotype or by shortening the duration of vincristine therapy in standard/high-risk patients with the CEP72 CC or CT genotype. Secondary Therapeutic Objectives: - To estimate the event-free survival and overall survival of children with ALL and to assess the non-inferiority of TOTXVII compared to the historical control given by TOTXVI. - To estimate the event-free survival and overall survival of children with LLy when ALL diagnostic and treatment approaches are used. - To evaluate the efficacy of blinatumomab in B-ALL patients with end of induction MRD ≥0.01% to <1% and those (regardless of MRD level or TOTXVII risk category) with the genetic subtypes of BCR-ABL1, ABL-class fusion, JAK-STAT activating mutation, hypodiploid, iAMP21, ETV6-RUNX1-like, MEF2D, TCF3-HLF, or BCL2/MYC or with Down syndrome, by comparing event-free survival to historical control from TOTXVI. - To determine the tolerability of combination therapy with ruxolitinib and Early Intensification therapy in patients with activation of JAK-STAT signaling that can be inhibited by ruxolitinib and Day 15 or Day 22 MRD ≥5%, Day 42 MRD ≥1%, or LLy patients without complete response at the End of Induction and all patients with early T cell precursor leukemia. Biological Objectives: - To use data from clinical genomic sequencing of diagnosis, germline/remission and MRD samples to guide therapy, including incorporation of targeted agents and institution of genetic counseling and cancer surveillance. - To evaluate and implement deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequencing-based methods to monitor levels of MRD in bone marrow, blood, and cerebrospinal fluid. - To assess clonal diversity and evolution of pre-leukemic and leukemic populations using DNA variant detection and single-cell genomic analyses in a non-clinical, research setting. - To identify germline or somatic genomic variants associated with drug resistance of ALL cells to conventional and newer targeted anti-leukemic agents in a non-clinical, research setting. - To compare drug sensitivity of ALL cells from diagnosis to relapse in vitro and in vivo and determine if acquired resistance to specific agents is related to specific somatic genome variants that are not detected or found in only a minor clone at initial diagnosis. Supportive Care Objectives - To conduct serial neurocognitive monitoring of patients to investigate the neurocognitive trajectory, mechanisms, and risk factors. - To evaluate the impact of low-magnitude high frequency mechanical stimulation on bone mineral density and markers of bone turnover. There are several Exploratory Objectives.
Lead Sponsor
Stanford Investigators
- Norman J. Lacayo, MD
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Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment Not Recruiting
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The purpose of this study is to test the safety of neratinib at different dose levels and to find out what effects, good and bad, it has on the patients and the cancer.

Stanford is currently not accepting patients for this trial. For more information, please contact Norman Lacayo, MD, 650-723-5533.
Lead Sponsor
Stanford Investigators
- Norman J. Lacayo, MD
View full details
Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage Recruiting
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The purpose of this study is to test the safety and determine the best dose of venetoclax and cytarabine when given with or without idarubicin in treating pediatric patients with acute myeloid leukemia (AML) that did not respond to treatment (refractory) or has come back after treatment (relapsed). PRIMARY OBJECTIVE: Determine a tolerable combination of venetoclax plus chemotherapy in pediatric patients with relapsed or refractory AML or acute leukemia of ambiguous lineage. The primary endpoints are the recommended phase 2 doses (RP2D) of venetoclax plus cytarabine and venetoclax plus cytarabine and idarubicin. SECONDARY OBJECTIVE: Estimate the overall response rate to the combination of venetoclax and chemotherapy in pediatric patients with relapsed or refractor AML or acute leukemia of ambiguous lineage. The secondary endpoints are the rates of complete remission (CR) and complete remission with incomplete count recovery (CRi) for patients treated at the RP2D.
Lead Sponsor
Stanford Investigators
- Norman J. Lacayo, MD
View full details
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia Not Recruiting
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The overall aim of this study is to determine if epigenetic priming with a DNA methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries evidence of a clinical efficacy signal as determined by minimal residual disease (MRD), event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as well as total reduction in DNA methylation and outcome assessments will be done to simultaneously obtain preliminary biological and clinical data for each DMTi in parallel. PRIMARY OBJECTIVES: - Evaluate the tolerability of five days of epigenetic priming with azacitidine and decitabine as a single agent DMTi prior to standard AML chemotherapy blocks. - Evaluate the change in genome-wide methylation burden induced by five days of epigenetic priming and the association of post-priming genome-wide methylation burden with event-free survival among pediatric AML patients. SECONDARY OBJECTIVES - Describe minimal residual disease levels following Induction I chemotherapy in patients that receive DMTi. - Estimate the event-free survival and overall survival of patients receiving a DMTi prior to chemotherapy courses.

Stanford is currently not accepting patients for this trial. For more information, please contact Norman J. Lacayo, MD, 650-497-8953.
Lead Sponsor
Stanford Investigators
- Tanja A. Gruber
- Norman J. Lacayo, MD
View full details
Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies Recruiting
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This phase I trial studies the best dose and side effects of CD19/CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy, and to see how well they work in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells (T cells) can attack cancer cells by recognizing and responding to the CD19/CD22 proteins. These proteins are commonly found on B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CD19/CD22-CAR T cells and chemotherapy may work better in treating children or young adults with B acute lymphoblastic leukemia.
Lead Sponsor
Stanford Investigators
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A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children Recruiting
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The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.
Lead Sponsor
Stanford Investigators
- Sheri Spunt
- Norman J. Lacayo, MD
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Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I Not Recruiting
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The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease the number of leukemia cells, but it could also cause additional side effects. Bortezomib and vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other cancers in adults, but they have not been approved for treating children with leukemia. With this research, we plan to meet the following goals: PRIMARY OBJECTIVE: - Determine the tolerability of incorporating bortezomib and vorinostat into an ALL chemotherapy backbone for newly diagnosed infants with ALL. SECONDARY OBJECTIVES: - Estimate the event-free survival and overall survival of infants with ALL who are treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone. - Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR. - Compare end of induction, end of consolidation, and end of reinduction MRD levels to Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant outcomes.

Stanford is currently not accepting patients for this trial. For more information, please contact Norman J. Lacayo, MD, 650-497-8953.
Lead Sponsor
Stanford Investigators
- Tanja A. Gruber
- Norman J. Lacayo, MD
View full details
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects Not Recruiting
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The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.

Stanford is currently not accepting patients for this trial. For more information, please contact SPECTRUM, .
Lead Sponsor
Stanford Investigators
- Norman J. Lacayo, MD
View full details
Genome, Proteome and Tissue Microarray in Childhood Acute Leukemia Not Recruiting
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We will study gene and protein expression in leukemia cells of children diagnosed with acute leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis in order to: (a) develop better means of diagnosis and (b) more accurately choose the best therapy for each patient.

Stanford is currently not accepting patients for this trial. For more information, please contact Norman J Lacayo, 650-723-5535.

Lead Sponsor
- Stanford University
Stanford Investigators
View full details

2023-24 Courses

Independent Studies
- Directed Reading in Pediatrics
  PEDS 299 (Aut, Win, Spr, Sum)
- Early Clinical Experience
  PEDS 280 (Aut, Win, Spr, Sum)
- Graduate Research
  PEDS 399 (Aut, Win, Spr, Sum)
- Medical Scholars Research
  PEDS 370 (Aut, Win, Spr, Sum)
- Undergraduate Directed Reading/Research
  PEDS 199 (Aut, Win, Spr, Sum)

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Norman J. Lacayo, MD

Associate Professor of Pediatrics (Hematology and Oncology)

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Stanford Investigators

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2023-24 Courses