Adolescent and Young Adult Protocol List

ACNS0232: Radiotherapy Alone vs. Chemotherapy Followed by Response-based Radiotherapy for Newly Diagnosed Primary CNS Germinoma

Physician Summary: ≥ age 3 and ≤ age 30, Newly Dx: XRT vs Carboplatin + Etoposide f/b response based XRT + Chemo

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

Physician Summary:

≤ age 21; Newly Dx: RT+ Vincristine +/- Carboplatin f/b Maint +/- Continuous Isotretinoin

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

Physician Summary: ≤ age 30: Single vs. Tandem Myeloblative as Consolidation Therapy

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

Physician Summary: < age 30; Newly Diagnosed; Stages I&II: Observation vs EE4A vs DD4A; Stage III: DD4A + XRT or Offer AREN0533

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

Physician Summary: < age 30, Newly Dx Higher Risk: VCR, AMD, DOXO per DD4A for 2 cycles + DD4A vs Regimen M

AREN0321: Treatment of High Risk Renal Tumors

Physician Summary: ≤ age 30, Newly Diagnosed Stage I-IV, Chemo –vs- Surgery Only (Ancillary AREN03B2 Required)

AALL03B1: Classification of Acute Lymphoblastic Leukemia

Physician Summary: ALL/Mandatory Biology Classification Companion to AALL0232

AALL0232: High Risk B-Precursor Acute Lymphoblastic Leukemia

Physician Summary: < 30 years of age, High Risk B-precursor (Pre-requisite = Ancillary AALL03B1)

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)

Physician Summary: Age 0-30; Newly Diag. T-Cell ALL; Methotrexate, Nelarabine and Augmented BFM Therapy (Prerequisite AALL03B1)

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

Physician Summary:   ≤ age 30; Initial Intermed-Risk Relapse of B-precursor: Standard VCR Dosing vs Intensive VCR Dosing

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

Physician Summary: < age 31; Relapsed B-Precurser: Reinduction Chemo + Epratuzumab

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

Physician Summary: < 30 years of Age, Late Isolated Extramedullary Relapse, (Pre-requisite = Ancillary AALL03B1)

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

Physician Summary: <30 years; DeNovo Acute AML: Gemtuzumab Ozogamicin (Mylotarg®) + Conventional Chemo

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

Physician Summary: ≤ age 21, Newly diagnosed Stage I or IIA: AV-PC Response dependent, RT

AHOD0121: A Phase II/III Study of Immunomodulation After High Dose Myeloablative Therapy with Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin Disease

Physician Summary: < 30 yr of age: Immunomodulation s/p ASCR

COG AHOD0521: A Phase II Study of Bortezomib (PS-341, Velcade™; IND 58443, NSC 681239) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Relapsed/Refractory Hodgkin Disease

Physician Summary: Age 0-30; Relapsed/Refractory; Bortezomib in Combination w/ Vinorelbine

AHOD0321: A Phase II Study of Weekly Gemcitabine and Vinorelbine in Children with Recurrent or Refractory Hodgkin Disease

Physician Summary: <30 years of age, Recurrent or Refractory: Gemcitabine + Vinorelbine

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/Lymphoma Treated with LMB/FAB Therapy

Physician Summary: <30 years; Newly Dx, Advanced B-Cell: LMD/FAB +/- Rasburicase to Reduction Phase

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

Physician Summary: < age 30; Prior to Initiation of any Cisplatin Therapy: Audiological Eval prior to baseline, prior to each dose & 1 post Rx eval

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

Physician Summary: < age 30; High Risk: Anti-GD2 Following ASCR

ARST0321: A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy

Physician Summary: < 18 years at original Dx; Recurrent or non amenable to standard therapy: Sulindac + Tamoxifen

COG-AEWS07P1: A Pilot Study of Chemotherapy Intensification by adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents with an Interval Compression Schedule in Newly Diagnosed Patients with Localized Ewing Sarcoma Family of Tumors

Physician Summary: Age <30, Newly Diagnosed and Localized: Standard VTC vs Interval Compression Schedule

COG-AEWS0521: A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND# 7921) Combined with Vincristine, Topotecan and Cyclophosphamide in Patients with First Recurrent Ewing Sarcoma

Physician Summary: Age >1 and <30, First Recurrent: VTC +/- Bevacizumab

AEWS0331: European Ewing Tumor Working Initiative of National Groups Ewing Tumor Studies 1999 (EURO-E.W.I.N.G.99)

Physician Summary: < 50 yr of age; Isolated Pulmonary or Pleural Mets

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

Physician Summary: < age 30, Surgery vs Surgery + XRT vs Surgery + Chemo + XRT/Surgery vs Chemo + XRT + Surgery + Chemo + XRT/Surgery (Chemo = Ifosfomide + Doxirubicin)

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

Physician Summary: Newly Dx, < 50 years old: VAC +/- XRT

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

Physician Summary: < age 50; Newly Diagnosed: VAC vs VAC alternating w/ VI; Includes XRT

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

Physician Summary: First Pulmonary Recurrence, < 39 years old: Aerosolized GM-CSF

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

Physician Summary: Resectable/Histological Response to Pre-Operative Chemotherapy

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

Physician Summary: ≤ age 40; No Prior Chemo; Feasibility & Dose Discovery Analysis of Zoledronic Acid with Concurrent Chemo