COG APPROVED & ACTIVE
PROTOCOLS
AALL02P2 Treatment of Late Isolated Extramedullary Relapse from Acute
Lymphoblastic Leukemia (ALL) (Initial CR1 > 18 months)
Eligibility: Ages > 18 months and < 30 years of age at
relapse
Diagnosis
of ALL (either B-precursor or T-
Lineage)
in first BM remission with first
isolated
CNS and/or testicular relapse
Length of initial complete remission must
be
>18 months from the time of
initial diagnosis
Total anthracycline dosage must be <360mg/m2
Must be enrolled on AALL03B1 banking study
AALL0232 High Risk B-Precursor Acute Lymphoblastic Leukemia
Eligibility: Ages 1 – 30 years
of age, inclusive
Newly
diagnosed B-precursor ALL
WBC Criteria:
Age
1.00-9.999: WBC >50,000
Age
10.00-30.999: any WBC
Prior
Steroid therapy: any WBC
Testicular
disease: any WBC
No
prior systemic chemotherapy except steroids and IT cytarabine
Must be enrolled on AALL03B1 banking
study
AALL03B1 Classification of Acute Lymphoblastic Leukemia
Eligibility: Age < 31 years
of age
Newly diagnosed acute leukemia suspected to be
ALL:
> 25% blasts on a bone marrow aspirate or
pathologic
diagnosis on a bone marrow biopsy or
complete
blood count documenting the presence of
at
least 10,000 WBC and at least 25% circulating
blasts.
Samples
must be provided to the reference and/or
COG-approved
cytogenetics lab (Genzyme
Genetics
is an approved lab)
If
blast morphology is obviously myeloid, or whose
blasts
are myeloperoxidase positive should not be
enrolled.
AALL0331 Standard Risk B-Precursor Acute Lymphoblastic Leukemia
Eligibility: Age between 1 year and < 10 years
Initial WBC count < 50,000; newly diagnosed B-precursor ALL;
No overt testicular disease
AALL0433 Intensive Treatment for Intermediate-Risk Relapse of Childhood
B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
Eligibility: Age < 30 years of age
Initial intermediate – risk relapse of B-precursor ALL
Intermediate-risk relapse is defined as:
AALL0434 Intensified
Methotrexate, Nelarabine (Compound 506U78;
Eligibility: Age < 30 years of age
Must
be enrolled on AALL03B1
Newly diagnosed T-cell ALL
ADVL04P2 A Feasibility Pilot and Phase 2 Study of Chemoimmunotherapy with Epratuzumab for ; Children with Relapsed CD22-Positive Acute Lymphoblastic Leukemia
Eligibility: Age > 2 and < 31 years of age
Must have immunophenotypic confirmation of CD22 expression
(> 25% expression)
AAML0531 A
Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combine with
Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children,
Adolescents and Young Adults.
Eligibility: Age < 30 years
of age
Untreated primary AML, who meet the criteria for
AML
with > 20% bone marrow blasts;
If
bone marrow aspirate or biopsy is clinically
prohibitive,
peripheral blood with an excess
of
20% blasts and in which adequate flow
cytometric
and cytogenetics/FISH testing is
feasible,
can be substituted for the marrow
exam
Patients
with cytopenias and bone marrow blasts
who
do not meet the customary criteria for the
diagnosis
of AML are eligible if they have a
karyotypic
abnormality characteristic of de novo
AML
(t(8;21)(q22;q22), inv(16)(p13;q22) or
11q23
abnormalities
or they have the unequivocal presence
of
megakaryoblasts, as set out in the WHO Myeloid
Neoplasm
classification
Patients
with isolated myeloid sarcoma
(myeloblastoma;
chloroma) are eligible.
AAML0431 The Treatment of Down Syndrome Children with Acute Myeloid
Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 years
Eligibility: Age < 4 years
Confirmed diagnosis of Down Syndrome (DS) or DS mosaicism;
Newly diagnosed AML or MDS with <30% blasts; no prior treatment
AALL05B1 A
Children’s Oncology Group Protocol for Collecting and Banking Relapsed Acute
Lymphoblastic Leukemia Research Specimens
Eligibility: Age- Must have been < 31 years of
age at the time of initial
diagnosis
Patient has ALL at first or subsequent marrow
relapse
with > 25% blasts in the bone marrow
and/or
peripheral blood.
No
treatment for the relapse with exception of IT
therapy.
Adequate
bone marrow or peripheral blood
specimens
must be sent.
AHOD0031 A Phase III Study of Dose-Intensive, Response Based
Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin
Disease
Eligibility: Ages 0-21 years
inclusive
Newly Diagnosed, pathologic confirmed Hodgkin
Disease who meet
the follow clinical stages:
All
Stage IB
All
Stage IIB
Stage
IA only with bulk disease
Stage
II A only with bulk disease
All
Stage IAE, IIAE
All
Stage IIIA, IIIAE, IIIAS, IIIAE+S
All
Stge IVA, IVAE
AHOD03P1 Treatment
of Children with Newly – Diagnosed Low Stage
Lymphocyte
Predominant Hodgkin Disease (LPHD)
Eligibility: Age 0-21 years
inclusive
Newly-diagnosed,
untreated, biopsy proven lymphocyte
predominant
Hodgkin disease
Clinical
Stages:
IA
without bulk disease
II
A without bulk disease
No
previous chemo or radiation, No systemic
Corticosteroids within 30 days
AHOD0431 A
Phase III Study for the Treatment of Children and Adolescents with Newly
Diagnosed Low-Risk Hodgkin Disease
Eligibility: Ages 0-21 years
inclusive
Newly diagnosed, histologically confirmed Hodgkin
Disease
who meet the following criteria:
·
Stage IA, without
bulk disease
·
Stage II A,
without bulk disease
·
No lymphocyte
predominance histology
No
prior chemotherapy or radiation therapy
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
Eligibility: Age < 30 years
All patients with HD with either primary refractory or disease in first relapse
Histologic verification of Hodgkin disease at the time of relapse or
progression of disease.
Must have measurable disease
AHOD04B1 Hodgkin Disease Banking Study
Eligibility: Ages 0-21 years inclusive
Newly diagnosed or recurrent hodgkin disease
Samples needed are: tumor tissue, serum and peripheral blood
ANHL0131 A
Phase III Study of Treatment of Advanced Stage Anaplastic Large Cell Lymphoma
(ALCL) with Standard
Eligibility: Age < 21 years
Newly diagnosed with CD30 positive anaplastic large
cell
lymphoma, Murphy stage III and IV
Slides
must be sent for central review
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 (SQT)
Eligibility: Age < 31 years
Must have had solid organ transplantation
Criteria
in Non-Fulminant (NF) PTLD (NF_PTLD)
PTLD
histologic diagnosis
CD20
positivity
EBV
positivitity-EBERs in-situ hybridization
(preferred)
&/or LMP immunoperoxidase
staining
Criteria
in Fulminant (F)-PTLD (F_PTLD) patients
PTLD
histologic diagnosis
CD20
positivity
EBV
positivitity-EBERs in-situ hybridization
(preferred)
&/or LMP immunoperoxidase
staining
ANBLOOB1 Neuroblastoma Biology Studies
Eligibility: No age restriction
Newly
diagnosed neuroblastoma, ganglioneuroblastoma
Or
ganglioneuroma (maturing subtype)
Must
be enrolled within 2 weeks of diagnosis and the INSS
stage
must be know before enrollment.
ANBL0032 Phase III Randomized Study of Chimeric Antibody 14.18 in High
Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Eligibility: Age < 31
Diagnosed with Neuroblastoma and categorized as high risk; Must have
achieved CR, VGPR or PR following frontline therapy prior to ASCT
evaluation.
ANBL00P2 Perinatal Neuroblastoma, Expectant Observation
Eligibility: Age < 6 months
Disease must be limited to the adrenal gland; no prior treatment
ARST0321 A Phase II Study
of Sulindec and Tamoxifen in Patients with
Desmoid
Tumors That are Recurrent or Not Amenable to
Standard
Therapy
Eligibility: Must have been <
18 years of age when
originally
diagnosed
Must
have biopsy proven desmoid tumor, patients with
Lipofibromatosis
or desmoplastic fibroma of bone (both
thought to be synonymous with DT)
Patients
with newly diagnosed DT are eligible if (a) they
have
had no prior therapy and (b) they have disease for
which
complete surgical resection and/or radiation
therapy
is not thought to be feasible.
Patients
with recurrent DT are eligible if (a) they have
radiographically
documented recurrent or progressive
disease,
(b) prior anti-tumor therapy has not included
treatment
with non-steroidal anti-inflammatory or
estrogen
antagonists and (c) they have had no chemotherapy or RT for the
present recurrence
Must
have measurable disease.
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
Eligibility: Age must be < 50
years
Newly
diagnosed with embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell
variants of embryonal
RMS
or embryonal ectomesenchymoma.
Must
be enrolled on D9902
ARST0332 Risk Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft
Tissue Sarcoma (NRSTS)
Eligibility: Age < 30 years
Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma
Must be enrolled on D9902 for central review and confirmation of diagnosis
ARST0531 Randomized Study of Vincristine, Dactinomycin and
Cyclophosphamide (VAC) versus VAC alternating with
Vincristine and Irinotecan (VI) for Patients with Intermediate-
Risk Rhabdomyosarcoma
Eligibility: Age < 50 years
Must
be enrolled on D9902
Must have Intermediate – risk RMS defined as:
·
Embryonal,
botryoid, or spindle cell RMS, or ectomesenchymoma: Stage 2 or 2 and Group III
or
·
Alveolar RMS:
Stage 1-3 and Group I-III
No
prior chemotheraoy or radiation unless tranferring from ARST0331 (low risk study)
ARST0431 Intensive Multi-Agent Therapy, Including Dose-Compressed
Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/
Cyclophosphamide (VDC) for Patients with High-Risk
Rhabdomyosarcoma
Eligibility: Age < 50 years
Newly
diagnosed, biopsy proven metastatic
rhabdomyosarcoma
or ectomesenchymoma
(Stage
IV, Clinical Group IV)
Prior
enrollment on D9902 to confirm local histologic
Diagnosis
No
prior chemotherapy or radiotherapy.
D9902 A COG Protocol for Collecting and Banking Soft Tissue
Specimens
Eligibility: Age < 50
years
Must
have diagnosis of Rhabdomyosarcoma (RMS) or
Non-rhabdomyosarcoma soft
tissue sarcoma (NRSTS,
Including chordoma, desmoid fibromatosis,
desmoplastic
round cell tumors, malignant
rhabdoid
tumors and undifferentiated embryonal
sarcoma
of the liver.
Tissue
must be sent for central pathologic review
AGCT0132 A Phase III Study
of Reduced Therapy in the Treatment of
Children with Low and Intermediate Risk
Extracranial Germ
Cell Tumors
Eligibility: Age < 21 except patients with testicular
primary tumors must be < 15 years of age.
Primary extracranial germ cell tumors which are
histologically
verified to by yolk sac (EST) tumor,
embryonal
carcinoma, choriocarcinoma or a mixed
germ
cell tumor which may be immature, mature
teratoma,
dysgerminoma, or seminoma mixed with one
of
the previously mentioned tumors.
AEWS0331 European
Eligibility: Age <50 years of age
Isolated
pulmonary or pleural metastases at the initial
diagnosis
of Ewing Sarcoma
No
previous chemotherapy
AEWS02P1 A Pilot Study of Low-Dose Antiangiogenic Chemotherapy in
Combination with standard Multiagent Chemotherapy for
Patients with Newly-Diagnosed
Metastatic
Eligibility: Age < 50 years of age.
Newly diagnosed metastatic Ewing
Sarcoma family of
tumors of the
bone or soft tissues, excluding
the central
nervous system. Paraspinal tumors
of extra-dural
origin and Askin’s tumor of the
chest wall are
eligible.
No prior treatment.
AEWSO2B1 A
Groupwide Biology and Banking Study for
Eligibility: No age restriction
Specimen
submission required.
AEWS0621 Phase II Trial of Intermediate-Dose Cytarabine to Modulate
EWS/FLI for Children and Young Adults with Recurrent or
Refractory Ewing Sarcoma
Eligibility: Age < 30
Diagnosis of Ewing sarcoma or PNET
Must have at least one site of measurable disease involving lung or soft tissue
AOST0221 A Phase II Study of Aerosolized GM-CSF (NSC#613795,
Recurrence of Osteosarcoma
Eligibility: Age < 39 years of age
Histologic
verification of osteosarcoma at original dx.
Must
have resectable pulmonary nodule(s), First
recurrence
of osteosarcoma.
No
other metastatic sites.
Must
have only received one prior treatment regimen.
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 – A Phase III Intergroup Study
Eligibility: Age > 5 and < 40 years of age
Must have high grade osteosarcoma. This includes second
Malignancies. Rapid central review of diagnostic biopsy
materials is
Required. Site of the primary tumor must be in:
·
Long bone of
upper limb, scapula
·
Short bone of
upper limb
·
Long bone of
lower limb
·
Short bone of
lower limb
·
Vertebral column
·
Ribs, sternum,
clavicle
·
Pelvic bones,
sacrum, coccyx
Craniofacial
osteosarcom is NOT included
All
tumor (primary, metastatic, or both) is resectable or is expected to
Become
resectable after the intital chemotherapy
No
previous treatment for osteosarcoma or previous chemotherapy for any
disease.
Previous radiotherapy for a
prior cancer (other than osteosarcoma) is permitted
P9851 Osteosarcoma Biology Protocol: Companion to Group-Wide
Therapeutic Studies
Eligibility: No age restriction
Specimen
submission required.
ACNS0121 A Phase II Trial of Conformal RT for Pediatric Patients with
Localized Ependymoma, Chemotherapy Prior to Second Surgery
For Incompletely Resected Ependymoma and Observation for
Completely Resected, Differentiated, Supratentorial Ependymoma
Eligibility: Age > 12 months
and < 21 years og age
Must
be enrolled within 56 days of initial surgical resection
Histologically
confirmed intracranial ependymoma.
Patients with differentiated ependymoma or anaplastic
ependymoma are eligible.
Ineligible tumors:
primary spinal cord ependymoma,
myxopapillary ependymoma, subependymoma,
ependymoblastoma or mixed gliomas.
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
Eligibility: Age < 25 years of age.
Eligible
Histological Diagnosis:
Endodermal
sinus tumor
Embryonal
carcinoma
Choriocarcinoma
Immature
teratoma and teratoma with
malignant
transformation
Mixed
germ cell tumor
Any Histologically confirmed
germinoma tumor with
elevation
of serum and/or CSF beta HCG>50 IU/dl
or
any elevation of serum and/or CSF alpha
fetoprotein >10 IU/L
Histologically
unconfirmed pineal and/or suprasellar
tumors
with serum and/or CSF tumor markers
of
beta HCG > 50IU/dl or any elevation of
alpha
fetoprotein > 10 IU/l
ACNS0331 A Study Evaluating Limited Target Volume Boost Irradiation and
Reduced Craniospinal Radiotherapy 18.00 Gy and Chemotherapy
In Children with Newly Diagnosed Standard Risk
Medulloblastoma: A Phase III Double Randomized Trial
Eligibility: Age < 22 years
of age.
Posterior
fossa medulloblastoma with presence of minimal
volume,
non-disseminated disease. Patients with
brain
stem involvement are eligible.
No
prior treatment.
ACNS0221 A Phase II Study of Conformal Radiotherapy in Patients with
Low-Grade Gliomas
Eligibility: Age > 3 and < 21 years of age
Histological Diagnosis of : juvenile pilocytic astrocytoma (JPA); pleomorphic JPA; diffuse astrocytoma (fibrillary,
Gemistocytic, giant cell or pleomorphic astrocytoma); low-
grade oligoastrocytoma; low-grade oligodendroglioma; or
low-grade glioma NOS
ACNS02B3 A Children Oncology Group Protocol for Collecting and Banking
Pediatric Brain Tumor specimens
Eligibility: No age restriction
Specimen
submission required.
AREN03B2 Renal Tumor Classification, Biology and Banking Study
Eligibility: Age < 30 years
old at time of dx
Tumors
of the following histologic types:
Nephroblastic
Tumors including
Nephroblastoma
(Wilms Tumor)
Favorable histology
Anaplasia (Diffuse, Focal)
Nephrogenic
rests and nephroblastomatosis
Cystic
Nephroma and Cystic Partially
Differentiated
Nephroblastoma
Metanephric
Tumors
Metanephric Adenoma
Metanephric Adenofibroma
Metanephric Stromal Tumor
Mesoblastic
Nephroma
Cellular,
Classic, Mixed
Clear
Cell Sarcoma
Rhabdoid
Tumor – any malignant rhabdoid tumor
occurring
outside the CNS
Renal
epitheloid tumors of childhood:
Papillary
renal cell carcinoma
Renal
medullary carcinoma
Renal
tumors with Xp11.2 translocations
Oncocytic
renal neoplasms following
Neuroblastoma
Angiolipoma
Ossifying
renal tumor of infancy
Specimens
and copies of imaging studies must be
Submitted
within 10 days of diagnostic procedure
AREN0321 Treatment of High Risk Renal Tumors
Eligibility: Age must be <
30 years old at diagnosis
Newly
diagnosed with one of the following histological
Types:
·
Focal Anaplastic
Wilms Tumor
·
Diffuse
Anaplastic Wilms Tumor
·
Clear Cell
Sarcoma of Kidney
·
Malignant
Rhabdoid Tumor (renal or extra renal)
·
Renal Cell
carcinoma
(clear
cell, papillary, renal medullary, oncocytoid,
sarcomatoid,
chromophobe, collecting duct, carcinoma associated with
neuroblastoma, renal
cell carcinoma unclassified)
Must
be enrolled on AREN03B2
AREN0532 Treatment for Very Low, Low and Standard Risk Favorable
Histology Wilms Tumor
Eligibility: Age must be < 30 years
Newly
diagnosed Stage I-III favorable histology Wilms
Tumor,
confirmed by central pathology and
radiology
review.
Must
be enrolled on AREN03B2
AREN0533 Treatment of Newly Diagnosed Higher Risk Favorable
Histology Wilms Tumor
Eligibility: Age must be < 30 years
Newly diagnosed Stage IV favorable histology Wilms Tumor
with or without LOH 1p and 16q or
Newly diagn