Phase I / Phase II Protocols / Clinical Studies

For information on these and other studies, contact the Developmental Therapeutics team at recurrentcancer@stjude.org.

 

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

 
 

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

For: Acute lymphoblastic leukemia (ALL)

 
 

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF):A Phase IIB Randomized Placebo-Controlled Trial

For: congestive heart failure

 
 

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

 
 

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

 

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/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

 
 

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

 
 

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

 
 

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

For: Relapsed ALL

 
 

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 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

 
 

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