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TCI Clinical Research Protocols


  
1.  PEDIATRIC ONCOLOGY
  
a. By Specific Disease
 

Acute Lymphoblastic Leukemia (ALL)

AALL0631: A Study of Risk Directed Therapy for Infants with ALL: Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431)

AALL0433: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia: A Randomized Trial of Vincristine Strategies

AALL06N1: A Study of Neurocognitive Function in Children Treated for Acute Lymphoblastic Leukemia

ADVL04P2: A Feasibility Pilot and Phase 2 Study of Chemoimmunotherapy with Epratuzumab for Children with Relapsed CD22-Positive Acute Lymphoblastic Leukemia

AALL0434: Intensified Methotrexate, Nelarabine (Compound 506U78; IND#52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia

AALL05B1: A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens

AALL03B1: Classification of Acute Lymphoblastic Leukemia

AALL0331: Standard Risk B-precursor Acute Lymphoblastic Leukemia

AALL0232: High Risk B-precursor Acute Lymphoblastic Leukemia

  AALL02P2: Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (Initial CR1>/=18 months) 

ANHL01P1: A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphomas Treated with LMB/FAB Therapy

AALL03N1: Understanding the Role of Adherence and Ethnic Differences in Survival After Childhood ALL

Acute Myeloid Leukemia

AAML0431: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years

AAML0531: A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Adrenocortical Carcinoma

ARAR0332: Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy

Brain Tumors

ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

ACNS0122: A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery To Eliminate All Measurable Disease Prior to Radiotherapy For NGGCT

ACNS0221: A Phase II Study of Conformal Radiotherapy in Patients with Low Grade Gliomas

ACNS0224: A Phase I/II Study of Topotecan with G-CSF and Radiation Therapy in Children with Malignant Intrinsic Pontine Brainstem Gliomas of Childhood

ACNS02B3: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens 

ACNS02B1: Pre-clinical Pharmacology in Surgical Brain Tumor Specimens

Registry for Central Nervous System Atypical Teratoid/Rhabdoid Tumor

ACNS0331: A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

Headstart III: Dose-intensive Chemotherapy for Children Less Than 10 Years of Age, Newly-diagnosed with Malignant Brain Tumors: A Study of Intensive Induction Chemotherapy Followed by Consolidation with Myeloablative Chemotherapy and Autologous Stem Cell Rescue
 
Ewing Sarcoma

AEWS0621: A Phase II Trial Modulating EWS/FLI with Cytarabine for Children and Young Adults with Relapsed Ewing Sarcoma

AEWS02P1: A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in Combination with Standard Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma Family of Tumors 

AEWS02B1: A Groupwide Biology and Banking Study for Ewing Sarcoma

AEWSO331: European Ewing Tumor Working Initiative of National Groups Ewing Tumor Studies 1999 (EURO-E.W.I.N.G.99)

Germ Cell Tumors

AGCT0521: Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors with Paclitaxel, Ifosfamide and Carboplatin

AGCT0132: A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors

Hepatoblastoma

AEPI04C1: Low Birth Weight and Other Risk Factors for Hepatoblastoma

9346: Hepatoblastoma Biology Study and Tissue Bank

Hodgkin’s Lymphoma

AHOD0521: A Phase II Study of Bortezomib (Velcade, PS-341, IND # 58443) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Refractory/Recurrent Hodgkin Disease

AHOD04B1: Hodgkin's Disease Banking Study

AHOD0431: Phase III Study for the Treatment of Children and Adolescents with Newly Diagnosed Low-Risk Hodgkin Disease

AHOD3P1: Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

ALTE04N1: Health-Related Outcomes for Hodgkin's Disease Survivors

AHOD0031: A Phase III Group-wide Study of Dose Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin's Disease 

Langerhans Cell Histiocytosis

LCH III Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis

Melanoma

E1697: Phase III Randomized Study of Four Weeks High Dose INF Alpha-2b in Stage T2bN0, T3a-b, T4a-bN0, and T1-4, N1a, 2a, 3 (Microscopic) Melanoma - An ECOG Coordinated Intergroup Trial

Nasopharyngeal Carcinoma

ARAR0331: Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy

Neuroblastoma

ANBL0531: Response- and Biology-based Therapy for Intermediate-risk Neuroblastoma

ANBL0421: A Phase II Study of Irinotecan + Temozolomide in Children with Recurrent Neuroblastoma

ANBL00P3: Use of Intravenous Gammaglobulin Therapy for Patients with Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated with Chemotherapy and Prednisone

ANBL00B1: Neuroblastoma Biology Studies

ANBL00P2: Perinatal Neuroblastoma: Expectant Observation. A Children’s Oncology Group Pilot Study

ANBL0032: Phase III Randomized Study of Chimeric Anti-GD2 in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Non Hodgkin’s Lymphoma

ANHL0221: A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults with CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) following Solid Organ Transplantation (SOT)

ANHL04B1: Rare and Cutaneous Non Hodgkin's Lymphoma Registry 

ANHL01P1: A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphomas Treated with LMB/FAB Therapy

ANHL0131: A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) versus Consolidation with a Regimen Including Vinblastine

Osteogenic Sarcoma

AOST0221: A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND # 11042) in Osteosarcoma Patients with First Pulmonary Recurrence of Osteosarcoma

AOST0331: A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy

9851: Biology Studies in Osteosarcoma: Companion Study to Intergroup Therapeutic

Renal Tumors

AREN0533: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

AREN0532: Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor

AREN03B2: Renal Tumors Classification, Biology, and Banking Study

AREN0321: Treatment of High Risk Renal Tumors

Retinoblastoma

ARET0332: A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy


Rhabdomyosarcoma / Soft Tissue Sarcoma

ARST0332: Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

ARST0431: Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/ Doxorubicin/ Cyclophosphamide (VDC) for Patients with High-Risk Rhabdomyosarcoma

ARST0331: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal / Botryoid / Spindle Cell Rhabdomyosarcoma

D9902: A Group-wide Protocol For Collecting and Banking Pediatric Cancer Research Specimens - IRSG

b. New Agents (Phase I and Phase II Studies)
 

ADVL0525: A Phase II Study of Pemetrexed in Children with Recurrent Malignancies

c. Other Protocols
 
i) Supportive Care

ACCRN07: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)

ACCL0731: (HLMCC 0402) Glutamic Acid to Decrease Vincristine Toxicity in Children with Cancer

ACCL05C1: A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy

ABTR06C1: Pharmacokinetics of Daunomycin in Children

VZ-009: Safety and Efficacy of Varicella Zoster Immune Globulin (Human) (VariZIG™) in Patients At-Risk of Varicella Infection

A Pilot Study to Test for A Shortened Decision-Making Intervention for Cancer-Surviving Adolescents
 

ii) Late Effects

ALTE04N1: Health-Related Outcomes for Hodgkin's Disease Survivors
 
  ALTE03N1: Key Adverse Events after Childhood Cancer
  
iii) Biology Studies

ABTR04B1: Establishing Continuous Cell Lines from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies
 
2. STEM CELL TRANSPLANT
 
ASCT0431: A Randomized Trial of Sirolimus-Based Graft versus Host Disease (GVHD) Prophylaxis after Hematopoietic Stem Cell Transplantation (HSCT) in Relapsed Acute Lymphoblastic Leukemia (ALL)

ASCT0521: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible unrelated Donors

An Observational Extension Study to evaluate Long Term Outcomes in Subjects who received EX-Vivo Selectively Amplified Cord Blood Stem Cells in Study CB001-03

 
3. HEMATOLOGY
 
Thalassemia Clinical Research Network Registry Protocol

An International Randomized Controlled Trial of Immune Tolerance Induction for Patients with Severe Hemophilia A and Inhibitors to Factor VIII

Severe Chronic Neutropenia International Registry

A Phase III, Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 with or without Hydroxyurea Therapy in Patients with Sickle Cell Disease who have had 2 or More Acute Sickle-Related Painful Crises within the Preceding 12 Months
  
4. PSYCHOLOGY

Profiles of Executive Functioning with Survivors of Childhood Acute Lymphocytic Leukemia and Children with Attention Deficit Hyperactivity Disorder, Inattentive Type

The Assessment of Quality of Life in Children With Cancer Confronting Advanced Disease
 
 

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For more information, please contact us at

tel: (201) 996-5437 / fax: (201) 487-7340 / email: info@tcikids.com

The Tomorrows Children's Institute
DON IMUS - WFAN Pediatric Center for Tomorrows Children
The Joseph M. Sanzari Children's Hospital
Hackensack University Medical Center
30 Prospect Avenue
Hackensack, NJ  07601