Clinical Studies / Protocols

 

A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

For: Relapsed or refractory precursor B-cell acute lymphoblastic leukemia and lymphoma

 
 

A Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy and of Natural Killer Cell Transplantation Versus Conventional Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

For: acute myeloid leukemia (AML)

 
 

Phase I Study of Bevacizumab and Sorafenib Combined with Low Dose Cyclophosphamide in Patients with Refractory Solid Tumors and Leukemia

For: Recurrent or refractory solid tumors and leukemias

 
 

A Safety/Feasibility Trial of the Addition of the Humanized Anti-GD2 Antibody (hu14.18K322A) with and without Natural Killer Cells to Chemotherapy in Children and Adolescents with Recurrent/Refractory Neuroblastoma

For: Recurrent / refractory neuroblastoma

 
 

T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus NK Cell Transplantation in Patients with Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

For: Relapsed or refractory hematologic malignancies

 
 

A Reduced Intensity Conditioning Regimen with CD3-Depleted Hematopietic Stem Cells to Improve Survival for Patients with Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation

For: Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Juvenile Myelomonocytic Leukemia (JMML), Paroxysmal Nocturnal Hemoglobinuria (PNH), Hodgkin lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic Syndrome (MDS)

 
 

Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy for Favorable Risk Pediatric Hodgkin Lymphoma

For: Hodgkin lymphoma

 
 

First International Inter-Group Study for Nodular Lymphocyte Predominant Hodgkin's Lymphoma in Children and Adolescents

For: Lymphocyte predominant Hodgkin lymphoma

 
 

HLA - Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less than 2 Years of Age with Hematologic Malignancies

For: Leukemias (high risk hematologic malignancies)

 
 

International Pediatric Adrenocortical Tumor Registry Data Collection

For: adrenocortical carcinoma

 
 

A Pilot Feasibility Study of Gene Transfer for X-linked Severe Combined Immunodeficiency in Newly Diagnosed Infants Using a Self-Inactivating Lentiviral Vector to Transduce Autologous CD34+ Hematopoietic Cells

For: X-linked Severe Combined Immunodeficiency (SCID-X1)

 
 

A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) In High-Risk Abdominal Neuroblastoma

For: High risk abdominal neuroblastoma

 
 

Study for Newly Diagnosed patients with Acute Lymphoblastic Lymphoma

For: Acute lymphoblastic leukemia

 
 

Pilot Study of Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia

For: Acute lymphoblastic leukemia (ALL)

 
 

Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors

For: Refractory or relapsed leukemia (AML, T-ALL, CML, JMML), T-cell lymphoma, myelodysplastic syndrome, Ewing sarcoma (ESFT), rhabdomyosarcoma (RMS)

 
 

A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children with Relapsed or Refractory Solid Tumors or Lymphomas

For: Relapsed or refractory solid tumors or lymphomas

 
 

A Pilot Pharmacokinetic, Pharmacodynamic, and Feasibility Study of Sorafenib in Combination with Cytarabine and Clofarabine in Patients with Refractory or Relapsed Hematologic Malignancies

For: Acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (both AML and ALL), AML w/prior myelodysplastic syndrome (MDS), myelodysplastic / myeloproliferative neoplasms, biphenotypic leukemia

 
 

A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma after Radical Resection

For: Craniopharyngioma

 
 

Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects

For: Ewing sarcoma; rhabdomyosarcoma; primitive neuroectodermal tumors (PNET) of the musculoskeletal system; soft tissue sarcomas; other bone sarcomas; chordoma

 
 

Mature B-Cell Lymphoma and Leukemia Study III

For: Leukemia and lymphoma

 
 

A Phase I trial of the humanized anti-GD2 antibody (hu12.18K322A) in children and adolescents with neuroblastoma, osteosarcoma and melanoma

For: Neuroblastoma, osteosarcoma and melanoma

 
 

Phase I Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants with Diffuse Intrinsic Pontine Glioma and High-Grade Glioma

For: Progressive or recurrent pontine glioma or high-grade glioma

 
 

Phase I Study of Platelet Derived Growth Factor Receptor (PDGFR) Inhibitor Crenolanib in Children and Young Adults with Newly Diagnosed Diffuse Intrinsic Pontine Glioma and Recurrent High-Grade Glioma Including Diffuse Intrinsic Pontine Glioma

For: Newly diagnosed diffuse Intrinsic Pontine glioma and recurrent / progressive high grade glioma including diffuse intrinsic pontine glioma

 
 

A Phase I Study of 5-Fluorouracil In Children And Young Adults With Recurrent Ependymoma

For: Recurrent ependymoma

 
 

Risk-Adapted Therapy for Young Children with Embryonal Brain Tumors, High-Grade Glioma, Choroid Plexus Carcinoma or Ependymoma

For: Embryonal brain tumors, choroid plexus carcinoma or ependymoma

 
 

Total Therapy Study XVI for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia

For: Acute Lymphoblastic Leukemia

 
 

Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative Regimen

For: High risk hematologic malignancies

 

Non St. Jude Protocols

 

A Phase I dose escalation study of REOLYSIN, a replication competent reovirus, in pediatric patients with relapsed or refractory solid tumors

For: Recurrent solid tumors

 
 

A Phase I Study Of The C-Met Inhibitor Tivantinib (ARQ 197, IND#112603) In Children With Relapsed or Refractory Solid Tumors (ADVL1111)

For: Relapsed or refractory solid tumors or brain tumors

 
 

A Phase I Study of AMG 386 (IND#114215), An Angiopoietin Neutralizing Peptibody, In Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors (ADVL1115)

For: Relapsed or refractory solid tumors, including CNS tumors

 
 

A Phase I Study of XL184 (Cabozantinib, IND# 116059) In Children and Adolescents with Recurrent or Refractory Solid Tumors, Including CNS Tumors (ADVL1211)

For: Recurrent or refractory solid tumors, including CNS tumors

 
 

A Phase I Dose Escalation Study of Seneca Valley Virus (NTX-010), a Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients with Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors with Neuroendocrine Features

For: Neuroblastoma, rhabdomyosarcoma, Wilms tumor, retinoblastoma, adrenocortical carcinoma and carcinoid tumor

 
 

A Phase I/II Study of PF-02341066, An Oral Small Molecule Inhibitor Of Anaplastic Lymphoma Kinase (ALK) And C-Met, In Children With Relapsed/Refractory Solid Tumors And Anaplastic Large Cell Lymphoma

For: Relapses/refractory solid tumors and anaplastic large cell lymphoma

 
 

A Phase II Study of MLN8237 (IND#102984), A Selective Aurora Kinase Inhibitor, In Children with Recurrent/Refractory Solid Tumors and Leukemias (ADVL0921)

For: recurrent or refractory solid tumors (including rhabdoid and malignant germ cell tumors of the CNS) and leukemias

 
 

A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

For: Relapsed or refractory B-precursor acute lymphoblastic leukemia

 
 

Killer Immunoglobulin-Like Receptor (KIR) Incompatible Hematopoietic Cell Transplantation (HCT) for Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children’s Oncology Group (COG) Study (AAML05P1)

For: Refractory and relapsed acute myelogenous leukemia (AML)

 
 

A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Tumor (SCUSF 0901; ACCL0922) Site CTEP ID= TN024

For: Previously treated brain tumors

 
 

A phase I, multi-center, dose escalation study of CAT-8015 in children, adolescents and young adults with refractory CD22+ acute lymphoblastic leukemia (ALL), or non-Hodgkin’s Lymphoma (NHL) (CAT-8015-1004)

For: acute lymphoblastic leukemia (ALL), non-Hodgkin’s lymphoma (NHL), including lymphoblastic lymphoma, Burkitt’s lymphoma, and large cell lymphoma

 
 

A Phase II Study of Sunitinib (NSC# 736511, IND# 74019) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients - A Children’s Oncology Group (COG) Study (ACNS1021)

For: Recurrent, refractory or progressive glioma and ependymoma

 
 

A Phase II Randomized Trial of Lenalidomide (NSC#703813, IND#70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytoma and Optic Pathway Gliomas

For: Recurrent, refractory or progressive brain tumors

 
 

Phase II Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors

For: Newly diagnosed localize primary NGGCT or newly diagnosed localized germinoma

 
 

A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children with Newly Diagnosed High-Grade Gliomas

For: Newly diagnosed high grade gliomas

 
 

Phase III Randomized Trial of Maintenance Chemotherapy Versus Observation in Pediatric Patients (ages 1 to 21 yrs) With Newly Diagnosed Ependymoma Following Induction Chemotherapy and Post-Operative Radiation Therapy

For: Intracranial ependymoma

 
 

Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)

For: Diffuse intrinsic pontine gliomas

 
 

Defibrotide for Patients with Hepatic Veno-Occlusive Disease (VOD): A Treatment IND study

For: Gene therapy: hepatic veno-occlusive disease

 
 

A Pilot Study of Decitabine and Vorinostat with Chemotherapy for Relapsed ALL (TACL protocol T2009-003)

For: Relapsed ALL

 
 

A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma

For: Non-metastatic Ewing sarcoma

 
 

An Open-Label, Multi-Center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects with Confirmed Influenza Infection

For: Influenza

 
 

Low-dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial

For: For survivors of Hodgkin lymphoma

 
 

A Phase 2 Study of Ipilimumab in Children and adolescents (12 to < 18 years) with Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma

For: Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma

 
 

An Open-label, Multicenter, Single-arm, Phase I Dose-escalation with Efficacy Tail Extension study of R05185426 in Pediatric Patients with Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600

For: melanoma

 
 

A Phase I Pediatric Study of a Plerixafor Containing Regimen in Second Allogeneic Stem Cell Transplantation

 
 

A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients

For: Leukemia and other blood diseases

 
 

A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide) in T-ALL Relapse: A Joint Study of TACL and POETIC

For: Leukemia

 
 

Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

For: Human Immunodeficiency Virus

 
 

A Phase I Dose Finding Study Of Panobinostat In Children With Refractory Hematologic Malignancies

For: Relapsed acute lymphoblastic leukemia [ALL], acute myelogenous leukemia [AML], Hodgkin disease [HD] and non-Hodgkin’s lymphomas [NHL]

 
 

Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma/ Brain Tumor

For: Gliomas

 
 

A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Children with Recurrent or Refractory Medulloblastoma

For: Recurrent or refractory medulloblastoma

 
 

A Phase I /II Study of ABT-888, an Oral Poly (ADP-Ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, followed by ABT-888 and Temozolomide (TMZ), in Children with Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)

For: newly diagnosed diffuse intrinsic pontine gliomas (DIPG)

 
 

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil furamate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naïve Adolescents

For: HIV infections

 
 

Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy

For: Nasopharyngeal carcinoma

 
 

Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy

For: Adrenocortical tumors

 
 

Treatment of High Risk Renal Tumors

For: Wilms tumor, renal tumor

 
 

Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor

For: Wilms tumor

 
 

Treatment of Newly Diagnosed, Higher Risk, Favorable Histology Wilms Tumor

For: Wilms tumor

 
 

Treatment for Patients with Bilateral, Multicentric, or Bilaterally- Predisposed Unilateral Wilms Tumor

For: Wilms tumor

 
 

Randomised Study Of First Time Immune Tolerance Induction In Patients With Severe Type A Haemophilia With Inhibitor At High Risk Of Failure: Comparison Of Induction Of Immune Tolerance With FVIII Concentrates With Or Without Von Willebrand Factor

For: Type A haemophilia

 
 

A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

For: Extra-occular retinoblastoma

 
 

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

For: Rhabdomyosarcoma

 
 

A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab[IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC # 742460]) inCombination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma

For: Rhabdomyosarcoma

 
 

A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Combination with Intravenous Vinorelbine and Cyclophosphamide in Patients with Recurrent/Refractory Rhabdomyosarcoma

For: Recurrent or refractory rhabdomyosarcoma

 
 

A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients with Recurrent Osteosarcoma Localized to the Lung

For: recurrent osteosarcoma

 
 

Sparing Conversion to Abnormal TCD Elevation (SCATE) - a Phase III clinical trial to compare standard care (observation) with alternative therapy (hydroxyurea) for reducing the risk of converting to an abnormal TCD velocity in children with sickle cell anemia and conditional pre-treatment TCD velocities

For: Sickle cell anemia

 
 

TCD with Transfusions Changing to Hydroxyurea (TWiTCH): A Phase III randomized clinical trial to compare standard therapy (erythrocyte transfusions) with alternative therapy (hydroxyurea) for the maintenance of lowered TCD velocities in pediatric subjects with sickle cell anemia and abnormal pre-treatment TCD velocities

For: Sickle cell disease