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TCI Clinical Research Protocols


  
1.  PEDIATRIC ONCOLOGY
  
a. By Specific Disease
 

Acute Lymphoblastic Leukemia (ALL)

AALL07P4: A Pilot Study of Intravenous EZN-2285 (SC-PEG E. coli L-asparaginase, IND# 100594) or Intravenous Oncaspar in the Treatment of Patients with High-Risk Acute Lymphoblastic Leukemia (ALL)

AALL07P1: A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443 ) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

AALL0622: Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

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

AALL0232: High Risk B-precursor Acute Lymphoblastic Leukemia

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

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

Acute Myeloid Leukemia

AAML0523: A Phase I/II Study of CLOLAR (Clofarabine IND# 73,789) in Combination with Cytarabine in Pediatric Patients With Refractory/Relapsed Leukemia

AAML0631: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox, IND#103,331) During Consolidation

AAML07P1: A Phase II Pilot Study of Bortezomib (PS-341, Velcade, IND #58,443) Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia

AAML05P1: Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (HCT) for Refractory and Relapsed Acute Myelogenous Leukemia (AML) and Newly Diagnosed AML with Monosomy 7 or -5/5q- in Children

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

Adrenocortical Carcinoma

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

Brain Tumors

ACNS0333: Treatment of Atypical Teratoid/Rhabdoid Tumors of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation

ACNS0334: A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate

ACNS0621: Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma

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

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

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

AEWS07B1: A Children's Oncology Group Protocol for Collecting and Banking Ewing Sarcoma Specimens

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

AHEP0731: Treatment of Children With All Stages of Hepatoblastoma

Hodgkin's Lymphoma

AHOD0831: A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

AHOD04B1: Hodgkin's Disease Banking Study

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

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

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

ANBL0532: Phase III Randomized Trial of Single vs. Tandem Myeloablative as Consolidation Therapy for High-Risk Neuroblastoma

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

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


ANHL04B1: Rare and Cutaneous Non Hodgkin's Lymphoma Registry 


Osteogenic Sarcoma

AOST06B1: A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens

AOST06P1: Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma

Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine (L-MTP-PE): Compassionate Access for High-risk 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

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)

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

Solid Tumors

ADVL0821: A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND# 100947, NSC# 742460) in Children With Relapsed/Refractory Solid Tumors

 
b.

New Agents (Phase I and Phase II Studies)

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

ACNS0621: Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma

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

AREN0321: Treatment of High Risk Renal Tumors

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.

ADVL0821: A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND# 100947, NSC# 742460) in Children With Relapsed/Refractory Solid Tumors

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

AAML0523: A Phase I/II Study of CLOLAR (Clofarabine IND# 73,789) in Combination with Cytarabine in Pediatric Patients with Refractory/Relapsed Leukemia

AALL07P1: A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443 ) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

AAML07P1: A Phase II Pilot Study of Bortezomib (PS-341, Velcade, IND #58,443) Combined with Reinduction Chemotherapy in Children and Young Adults with Recurrent, Refractory or Secondary Acute Myeloid Leukemia

   
c. Other Protocols
 
i) Supportive Care

ACCL0431: A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

ADVL06B1: A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children with Cancer

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

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

 

ii) Late Effects

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

AAML08B1: Biology Study of Transient Myeloproliferative Disorder (TMD) in Children With Down Syndrome (DS)

ABTR01B1: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors

ABTR04B1: Establishing Continuous Cell Lines from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies
 
2. STEM CELL TRANSPLANT
 
Defibrotide for Patient With Hepatic Veno-Occlusive Disease (VOD): A Treatment IND Study (under CFR 312.34)

A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Non-Malignant Disease Using a Reduced-Intensity Preparatory Regime With Campath-1H, Fludarabine and Melphalan

Support Systems of Families With Children Undergoing Bone or Marrow Transplantation: A Psychosocial Perspective of Strengths, Challenges and Coping

Unrelated Donor Hematopoietic Cell Transplantation for Children with Severe Sickle Cell Disease Using a Reduced Intensity Conditioning Regimen

A Sample Repository For Allogeneic Unrelated Hematopoietic Stem Cell Transplantation

Fludarabine-based Conditioning for Allogeneic Marrow Transplantation from HLA Compatible Unrelated Donors in Severe Aplastic Anemia

A Multi-Center, Randomized, Double-Blind, Phase III Trial Evaluating Corticosteroids with Mycophenolate Mofetil vs. Corticosteroids with Placebo as Initial Systemic Treatment of Acute GVHD

Multi-Center, Open Label, Randomized Trial Comparing Single Versus Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients with High Risk Leukemia and Myelodysplasia

ASCT0631: 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

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

 
3. HEMATOLOGY
 
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

ALTE07C1: Neuropsychological, Social, Emotional and Behavioral Outcomes in Children with Cancer

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