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The Big Picture
Active Clinical Studies at Children's Hospital & Research Center at Oakland
Children's Hospital & Research Center at Oakland is committed to providing the most up-to-date information on currently active clinical studies within our institution. Tables listing all current studies, and organized by Principal Investigator, are provided and updated on a monthly basis.
In addition, please feel free to review this page monthly for highlights of the most recently approved active clinical studies.
Full List of All Active CHRCO Clinical Studies
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Clinical Studies Approved Within the Last Two Months:
Feasibility of Forearm Ultrasonography-Guided Nerve Blocks of Radial, Ulnar, and Median Nerves for Hand Procedures in the Pediatric Emergency Department
The purpose of this study is to determine the feasibility of forearm ultrasonography-guided nerve blocks of the radial, ulnar, and median nerves, performed by emergency physicians, to provide procedural anesthesia in the hand of pediatric patients in the pediatric ED.
A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of ProQuadTM Vaccine When Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers
Neisseria meningitidis is a dangerous germ that causes serious diseases like meningitis (an infection of the brain and spinal cord) and sepsis (an infection of the blood and body tissues), which may result in death and most commonly affects infants and young children. Parvin Azimi, MD, will be looking at 2 different vaccines, Meningococcal ACWY Conjugate (MenACWY) and ProQuadTM, to determine if they are effective when given together in 7 to 9 month old infants and 12 month old toddlers.
Respiratory Distress of the Newborn and Its Relationship to Group B Streptococcal Colonization
Parvin Azimi, MD, will conduct this prospective, population-based, non-interventional, minimum-risk study to compare GBS-colonized and non-colonized newborns with regards to the development of respiratory distress, pulmonary hypertension, and other morbidities. The role of bacterial phospholipids in the development of respiratory distress will also be evaluated to determine the role that intrapartum penicillin use may play in this morbidity. We hypothesize that “asymptomatic” GBS colonization in newborns constitutes as a risk factor for respiratory distress and that the use of intrapartum penicillin augments this risk.
A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Months Old, Inclusive (RAB-GRD-1003)
The objective of this open-label, multicenter, phase 1 study, led by Elizabeth Gleghorn, MD, is to evaluate the pharmacokinetics, pharmacodynamics (intraesophageal/intragastric pH, clinical global impressions, formulation palatability and GERD daily symptom diary) and safety of rabeprazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 months, inclusive (up to 11 months 29 days), with GERD.
A Phase III Study for the Treatment of Children and Adolescents with Newly Diagnosed Low Risk Hodgkin Disease (AHOD0431)
Optimal therapy for favorable risk Hodgkin disease in children and adolescents continues to evolve. Cure is reasonably expected in the great majority of children; however, the potential for long-term adverse sequelae of treatment remains significant. Identification of patients who can be cured with less therapy is an important mechanism by which to decrease the potential risk of long-term toxicity of therapy for survivors. In this study patients who experience a low risk relapse after CR (treated with chemotherapy only) will be retrieved with ifosfamide/vinorelbine (IV) and dexamethasone/etoposide/cisplatin/cytarabine (DECA) + IFRT. Low risk relapse is defined as meeting the same criteria as eligibility criteria for this study.
Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (ACCRN07)
This protocol, led by Carla Golden, MD, is designed to facilitate the systematic registration of pediatric and adolescent patients diagnosed with cancer into a Childhood Cancer Research Network (CCRN).
A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gaucher Disease
The primary objective of this study, led by Paul Harmatz, MD, is to compare the effects of GA-GCB and imiglucerase on hemoglobin concentration in patients with type 1 Gaucher disease.
Sweat Testing in CF Newborns Detected by Screening
Karen Hardy, MD, will be leading this study to: evaluate a uniform patient preparation protocol for sweat testing that includes salt supplementation and adequate fluid intake guidelines; determine the effect on sweat electrolytes of fluid and electrolyte status; and to assess for longitudinal changes in sweat electrolyte concentration and other clinical and laboratory parameters. The study is conducted within the context of the newly instituted California new born screening algorithm, which will identify newborns carrying a wide spectrum of CFTR mutations and with corresponding varying degrees of CFTR dysfunction and will likely include some infants with mild variants and thus only at risk for CFTR associated diseases.
Ketamine Sedation for Fracture Reduction in the Emergency Setting: A randomized prospective study comparing 4 vs. 6 hours NPO time
Scott Hoffinger, MD, aims to determine that 4 hours NPO appears to be safe for the administration of ketaime sedation for fracture reduction and determine that more prospective studies should be done to further investigate this finding.
Human blood for use in biological assays
Gregory R. Moe, PhD, has with his colleauges identified a novel sialic acid derivative, which refered to as neuraminic acid containing polysialic acid or neuPSA, that is expressed by pathogenic bacteria Neisseria meningitidis group B and C and in many human cancers including leukemias, lymphomas, melanomas, and neuroblastomas. The specific aims of this study are to evaluate functional activity of polyclonal antisera and monoclonal antibodies produced by immunization with neuPSA vaccines to: protect against disease caused by N. meningitidis group B and C, induce cytotoxicity in human cancer cell lines, and evaluate binding and possible cytotoxicity to normal blood-derived cells that have or have not been induced to divide by treatment with mitogenic agents.
Determining the Effective Dose of Folic Acid or of 5-Methyltetrahydrofolate (5MTHF) Administered Weekly or Daily Together with Iron as a Supplement that will Achieve a Desirable Iron and Folate Status of Women Populations
This research study led by Fernando Viteri, MD, is designed to estimate the effectiveness of taking 60mg of iron with two doses of either folic acid or 5-methyltetrahydrofolate (5MTHF) in improving the iron and folate nutrition, while maintaining vitamin B12 levels, of at risk groups. We will compare the results of this with participants who will take a placebo.
10 Week Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in the Treatment of the Cognitive Dysfunction Exhibited by Children with Down Syndrome
The objective of this study, led by Renee Wachtel, MD, is to evaluate the effectiveness and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down Syndrome as assessed in the domains of communication, daily living skills, and socialization.
A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source In Matched Sibling Donor Transplantation (COG ASCT0631 PBMTC SCT051)
Mark Walters, MD, is leading this ASCT0631 Phase III trial comparing two graft sources for allogeneic transplantation using HLA identical siblings as donors: bone marrow and filgrastim (G-CSF) stimulated bone marrow (G-BM) in children undergoing allogeneic transplantation for leukemia’s in which matched sibling donor transplantation is appropriate. The protocol is designed to implement a novel strategy to integrate transplant questions into treatment studies in the cooperative group setting, allowing patients on disease specific treatment protocols co-enrollment on a study designed to investigate a transplant-specific question in a manner which does not adversely impact the primary, disease specific, treatment question.
Compassionate Use Protocol for the Use of AMD3100 to Mobilize Peripheral Blood Stem Cells for Collection and Transplantation
AMD3100 is a potent and selective antagonist of the CXCR4 chemokine receptor and bocks binding of its cognate ligand, stromal cell-derived factor-1a (SDF-1a), also known as CXCL12. Mark Walters, MD, is investigating its use for the mobilization of stem cells prior to high dose chemotherapy in the treatment of multiple myeloma (MM), non-Hodgkin’s lymphoma (NHL), and other hematopoietic malignancies.
Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
This new study led by Chris Baker, MD, will investigate the efficacy of nebulized hyperonic saline in infants with viral bronchiolitis, the most common viral respiratory infection in young children and infants. In recent years, hypertonic saline has been shown to improve symptoms and decrease length of stay in small studies of patients with bronchiolitis. We hypothesize that nebulized hypertonic saline is more effective than normal saline in the treatment of uncomplicated viral bronchiolitis.
Follow-up of Children Diagnosed with Vitamin D Deficiency Rickets between 2000 and 2007: Current Vitamin D Status, Growth, Bone and Dental Health and Immune Status
Suruchi Bhatia, MD will compare the vitamin D status of case with control children, case children with a sibling, and case mothers with control mothers, and the growth, bone and dental health, and immune function markers between case children and control children and between case children and case siblings. In addition, Dr. Bhatia will evaluate the dietary, environmental, and genetic predictors of current vitamin D status in children and mothers.
ANBL0531: Response and Biology-Based Therapy for Intermediate-Risk Neuroblastoma
This study led by Carla Golden, MD, will build upon the reduction of therapy approach that was studied in the prior COG study for intermediate-risk neuroblastoma, A3961, while maintaining an overall 3-year OS rate of > 95% for the entire cohort. Patients will be risk-stratified using the following clinical and biologic variables: age, INSS stage, MYCN status, INPC histopathology classification, and tumor DNA index. Allelic status at chromosome bands 1p36 and 11q23 will be utilized in order to help define the duration of therapy, such that only patients whose tumors lack these alterations will be eligible for dose reduction.
A Multicenter, Randomized, Double-Blind, Parallel Group,TwoDose Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type I Gaucher Disease
The primary objective of this study, led by Paul Harmatz, MD, is to determine the efficacy of every other week dosing of GA-GCB at a dose of 60 U/kg in patients with type 1 Gaucher disease as measured by increases in hemoglobin concentration.
Spectrum of Iron Deficiency Anemia at Children's Hospital & Research Center at Oakland
Iron deficiency is a multi-system disorder with profound effects on the central nervous system. Numerous studies during the past 20 years have clearly defined an effect of iron deficiency on mental development and often on motor functioning as well. It is imperative that pediatricians and other professionals caring for infants and young children be more attentive to good nutritional practices. Ashutosh Lal, MD, will determine the number and age-distribution of children with iron deficiency seen in the hematology clinic at Children’s Hospital and Research Center Oakland.
Open Label, Dose Escalation, Phase I / Pilot Study Designed to Provide Preliminary Evidence of the Safety, Pharmacokinetics (PK), and Pharmacodynamic (PD) Activity of Pentosan Polysulfate Sodium (PPS) Given Orally as a Single Dose to Subjects with Sickle Cell Disease.
Safety measures will include clinical observations and tests of coagulation; measures of pharmacodynamic activity will include P-selection blocking activity in plasma (or serum); and microvascular blood flow will be determined by both computer-assisted intravital microscopy (CAIM) and laser Doppler velocimetry (LDV).
Multi-Center, Open Label, Randomized Trial Comparing Single versus Double Umbilical Cord Blood Transplantation in Pediatric patients with High Risk Leukemia or Myelodysplasia (BMT-CTN-0501)
The primary objective of this study, led by Mark Walters, MD, is to determine the efficacy of using two UCB units versus one UCB unit. The primary endpoint is one-year survival. The secondary objectives is to have patients randomized to the two study arms and compared for the following endpoints: disease-free survival, incidences of neutrophil and platelet engraftment, chimerism, acute graft-versus-host disease (GVHD), chronic GVHD, transplant-related mortality, infections, immune reconstitution, and relapse.
Full List of All Active CHRCO Clinical Studies
By Principal Investigator:
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