Read Thursday, October 14, 2010 text version

Pediatric Central IRB Meeting Agenda Thursday, July 14, 2011 11:00 a.m. ­ 1:55 p.m. Agenda

I.

General Business · Next Meeting: Thursday, August 11, 2011 Review/Approval of Minutes · June 9, 2011 Adverse Event Review Initial Review ACCL0922, A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor (Protocol Version Date 06/10/11)

II.

III. IV.

V.

Continuing Review ACNS0221, A Phase II Study of Conformal Radiotherapy In Patients with LowGrade Gliomas (Protocol Version Date 03/15/11)

VI.

Continuing Review 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: A Phase III Group-Wide Study (Protocol Version Date 06/15/11)

VII.

Continuing Review ANBL00P3, A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients with Neuroblastoma Associated Opsoclonus-MyoclonusAtaxia Syndrome Treated with Chemotherapy and Prednisone (Protocol Version Date 02/17/11)

VIII.

Continuing Review ARAR0331, Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study (Protocol Version Date 11/16/10)

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Pediatric Central IRB Meeting Agenda

Thursday, July 14, 2011 11:00 a.m. ­ 1:55 p.m.

IX.

Continuing Review ARST0332, Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age: A Groupwide Phase III Study (Protocol Version Date 04/13/11)

X.

Continuing Review AHOD03P1, Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD): A Groupwide Pilot Study (Protocol Version Date 09/30/09)

XI.

Continuing Review AHOD0431, A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease (Protocol Version Date 10/06/10)

XII.

Continuing Review 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 (ALL) or T-cell Lymphoblastic Lymphoma: A Groupwide Phase III Study (Protocol Version Date 06/02/11)

XIII.

Continuing Review AALL0433, Intensive Treatment for Intermediate-Risk Relapse of Childhood BPrecursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies. A Groupwide Phase III Study (Protocol Version Date 05/23/11)

XIV.

Expedited Review Approvals and Acknowledgements Includes studies and letters approved via expedited review and submissions acknowledged from June 3, 2011 ­ July 6, 2011. Please contact the Operations Office if you would like to review any of the following approved or acknowledged materials. Group Responses to Initial Reviews AALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk Bprecursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum: A Groupwide Phase III Study (Protocol Version Date 06/22/11) AALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk Bprecursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND#

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Pediatric Central IRB Meeting Agenda

Thursday, July 14, 2011 11:00 a.m. ­ 1:55 p.m.

73789, NSC# 606869) in the Very High Risk Stratum: A Groupwide Phase III Study (Protocol Version Date 06/30/11) Amendment Reviews AALL03B1, Classification of Acute Lymphoblastic Leukemia (Amendment #7, Protocol Version Date 05/16/11) 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 (ALL) or T-cell Lymphoblastic Lymphoma: A Groupwide Phase III Study (Amendment #7, Protocol Version Date 06/02/11) AALL07P4, A Pilot Study of Intravenous EZN-2285 (SC-PEG E. coli Lasparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients with High-Risk Acute Lymphoblastic Leukemia (ALL): A Limited Institution Pilot Study (Amendment #5, Protocol Version Date 06/03/11) ACCL0431, A Randomized Phase III Study of Sodium Thiosulfate (IND#72877, NSC#45624) for the Prevention of Cisplatin-Induced Ototoxicity in Children: A Groupwide Phase III Study (Amendment #2, Protocol Version Date 06/14/11) ACNS0333, Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System with Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation: A Phase III Group-Wide Study (Amendment #2, Protocol Version Date 06/15/11) 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: A Phase III Group-Wide Study (Amendment #2, Protocol Version Date 06/15/11) AHEP0731, Treatment of Children with All Stages of Hepatoblastoma: A Groupwide Phase III Study (Amendment #2, Protocol Version Date 06/08/11) ANBL0531, Response- and Biology-Based Therapy for Intermediate-risk Neuroblastoma: A Groupwide Phase III Study (Amendment #2, Protocol Version Date 05/19/11) ANBL09P1, A COG Pilot Study of Intensive Induction Chemotherapy and 131IMIBG/ Irinotecan/ Vincristine Followed by Myeloablative Busulfan-Melphalan (Bu-Mel) for Newly Diagnosed High-Risk Neuroblastoma: A Limited Institution Pilot Study (Amendment #2, Protocol Version Date 06/07/11) Group Responses to Amendment Reviews 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) (Amendment #3, Protocol Version Date 06/30/11) AALL08P1, Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study (Amendment #2, Protocol Version Date 06/17/11)

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Pediatric Central IRB Meeting Agenda

Thursday, July 14, 2011 11:00 a.m. ­ 1:55 p.m.

Continuing Reviews ADVL0524, Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults with Refractory Solid Tumors (Protocol Version Date 10/01/07) Acknowledgements AALL0331 Clarification of Re-consent Form for Amendment #7 (dated June 17, 2011), Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL): A Phase III Group-Wide Study AALL0331 Daunorubicin Shortage Recommendations (dated June 1, 2011), Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL): A Phase III Group-Wide Study AALL0433 Amendment #4 Activation ­ Effective June 13, 2011, Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies. A Groupwide Phase III Study AALL0434 Daunorubicin Shortage Recommendations (dated June 1, 2011), Intensified Methotrexate, Nelarabine (Compound 506U78; IND # 52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma: A Groupwide Phase III Study AALL0434 Daunorubicin Shortage Update and Enrollment (dated June 23, 2011), Intensified Methotrexate, Nelarabine (Compound 506U78; IND # 52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma: A Groupwide Phase III Study AALL0622 Daunorubicin Shortage Recommendations (dated June 1, 2011), Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase II/III Study AALL0622 Daunorubicin Shortage Update and Enrollment (dated June 23, 2011), Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase II/III Study AALL0631 Daunorubicin Shortage Recommendations (dated June 1, 2011), A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807): A Groupwide Phase III Study AALL0631 Daunorubicin Shortage Update and Enrollment (dated June 23, 2011), A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807): A Groupwide Phase III Study AALL07P4 Correction to COG Letter regarding the Treatment Recommendations for Based on Results from AALL0232 (dated February 25, 2011), A Pilot Study of Intravenous EZN-2285 (SC-PEG E. coli Lasparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients with High-Risk Acute Lymphoblastic Leukemia (ALL): A Limited Institution Pilot Study

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Pediatric Central IRB Meeting Agenda

Thursday, July 14, 2011 11:00 a.m. ­ 1:55 p.m.

AALL07P4 Daunorubicin Shortage Recommendations (dated June 1, 2011), A Pilot Study of Intravenous EZN-2285 (SC-PEG E. coli L-asparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients with HighRisk Acute Lymphoblastic Leukemia (ALL): A Limited Institution Pilot Study AALL07P4 Daunorubicin Shortage Update and Enrollment (dated June 23, 2011), A Pilot Study of Intravenous EZN-2285 (SC-PEG E. coli L-asparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients with HighRisk Acute Lymphoblastic Leukemia (ALL): A Limited Institution Pilot Study AALL0932 Additional Information Regarding Patients with iAMP21 (dated June 28, 2011), Treatment of Patients with Newly Diagnosed Standard Risk BPrecursor Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase III Study AALL0932 Patients Enrolled on AALL0932 with iAMP21 Are No Longer Eligible To Continue Post-Induction Therapy on AALL0932 Memo (dated June 23, 2011), Treatment of Patients with Newly Diagnosed Standard Risk BPrecursor Acute Lymphoblastic Leukemia (ALL): A Groupwide Phase III Study AAML0431 Daunorubicin Shortage Recommendations (dated June 1, 2011), The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years: A Groupwide Phase III Study AAML0431 Daunorubicin Shortage Update and Enrollment (dated June 23, 2011), The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years: A Groupwide Phase III Study AAML0531 Daunorubicin Shortage Recommendations (dated June 1, 2011), 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 AAML1031 Daunorubicin Shortage Update and Enrollment (dated June 23, 2011), A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD: A Groupwide Phase II/III Study AAML1031 Study Activation ­ Effective June 20, 2011, A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD: A Groupwide Phase II/III Study ACCL0933 Study Participation Restriction (dated June 28, 2011), A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML): A Groupwide Phase III Study ACCL0934 Study Activation ­ Effective June 20, 2011, A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT): A Groupwide Phase III Study ADVL0921 Partial Closure - Ewing's Sarcoma Stratum ­ Effective June 20, 2011, A Phase II Study of MLN8237 (IND# 102984), A Selective Aurora A Kinase Inhibitor in Children with Recurrent/Refractory Solid Tumors and Leukemias: A Phase II Study Limited to COG Institutions in the USA & Canada

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Pediatric Central IRB Meeting Agenda

Thursday, July 14, 2011 11:00 a.m. ­ 1:55 p.m.

AGCT0521 Study Closure to Accrual ­ Effective June 20, 2011, Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors with Paclitaxel, Ifosfamide and Carboplatin: A Groupwide Phase II Study AHEP0731 Temporary Closure of Stratum 4 ­ Effective June 6, 2011, Treatment of Children with All Stages of Hepatoblastoma: A Groupwide Phase III Study ANBL0532 Amendment #3 Activation ­ Effective June 6, 2011, Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma AOST0331 Study Closure ­ Effective June 30, 2011, 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 (IND# 12697): A Phase III Intergroup Study AOST0331 Updated PegIntron Investigator Brochure (Version Date 12/15/2010), 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 (IND# 12697): A Phase III Intergroup Study AREN0534 Amendment #2A Activation ­ Effective June 13, 2011, Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Groupwide Phase III Study

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