Download Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia
Title: COG ADVL04P2: A Feasibility Pilot and Phase 2 Study of Chemoimmunotherapy with Epratuzumab for Children with
Relapsed CD22-Positive Acute Lymphoblastic Leukemia.
Purpose: To determine the feasibility of administering epratuzumab as a single agent and in combination with chemotherapy, for
children with relapsed CD-22 positive B-precursor leukemia. To define and describe the toxicities of epratuzumab
administered alone and in combination with chemotherapy. To determine the antitumor activity of epratuzumab as a single
agent and in combination with cytotoxic chemotherapy in children with relapsed CD-22 positive B-precursor leukemia. To
estimate the remission re-induction rate and four-month event-free survival (EFS) for patients with early first relapse ALL
who receive epratuzumab in combination with cytotoxic chemotherapy.
Eligibility Children who are older than 2 years and younger than 31 years of age with CD22 positive Acute Lymphoblastic Leukemia
who have relapsed within 36 months of diagnosis.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Acute Lymphoblastic Leukemia
Title: High Risk B-precursor Acute Lymphoblastic Leukemia. (COG AALL0232)
Purpose: To improve the cure rate of children with high risk acute lymphoblastic leukemia, to find out if using high doses of
methotrexate instead of using lower doses of methotrexate with an escalating schedule can keep the cancer from returning
without causing more serious side effects, and to see how quickly patients respond to initial therapy (disease remission) and
how well they do following treatment can be linked to the presence or absence of very small numbers of leukemia cells in the
bone marrow on Day 29 of treatment.
Eligibility Patients must be greater than 1 and less than 31 years of age newly diagnosed with B-precursor Acute Lymphoblastic
Leukemia (ALL).
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 2
Current Enrollment: 2
August 27, 2010
Acute Lymphoblastic Leukemia
Title: Intensified Methotrexate, Compound 506U78 (Nelarabine: IND #52611) and Augmented BFM Therapy for Children and
Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia. (COG AALL0434)
Purpose: To determine, through randomization, the relative safety and efficacy of the additon of Nelarabine (Compound 506U78) to
augemeted BFM therapy (Regimen C, CCG-1961). To determine the relative safety and efficacy of high dose methotrexate
(5gm/m2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue plus PEG-Asparaginase
(Capizzi I) delivered during Interim Maintenance.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 3
August 27, 2010
Acute Lymphoblastic Leukemia
Title: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A
Randomized Trial of Vincristine Strategies. (COG AALL0433)
Purpose: To establish the efficacy of an intensive chemotherapy regimen (based on POG 9412) for patients with intermediate-risk
relapse of childhood B-precursor ALL (defined as late marrow/combined relapse greater than or equal to 36 months from
diagnosis or early isolated CNS/testicular relapse less than 18 months from diagnosis.
Eligibility Patients between 1 year and 29.99 years of age (inclusive) at the time of relapse will be eligible. Patient with an initial
intermediate-risk relapse of B-precursor Acute Lymphoblastic Leukemia (ALL) will be eligible.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Acute Lymphoblastic Leukemia
Title: COG AALL0631: 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).
Purpose: To compare the 3-year event-free survival (EFS) of infants with MLL-R ALL randomized to treatment with a modified P9407
chemotherapy backbone with or without the FLT3 inhibitor lestaurtinib. To determine a safe, tolerable and biologically
addictive dose of lestaurtinib given in sequential combination with chemotherapy in MLL-R infants. To characterize the
pharmacokinetics and pharmacodynamics of lestaurtinib in infants when given at the proposed dose in sequential combination
with chemotherapy. To identify molecular mechanisms of resistance to lestaurtinib in leukemic blasts. To describe levels of
minimal residual disease in infants with ALL within the context of the proposed therapy, and correlate with outcome. To
identify gene expression patterns in diagnostic infant leukemia samples that correlate with outcome within the context of the
proposed therapy. To describe the outcome of infants with MLL-G ALL treated with a modified P9407 chemotherapy
backbone that includes an extended Continuation phase.
Eligibility Infants who have been diagnosed with Acute Lymphoblastic Leukemia (ALL)
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 1
August 27, 2010
Acute Lymphoblastic Leukemia
Title: COG AALL0622: Intensified Tyrosine Kinase Inhibitor Therapy (Desatinib: IND #73969, NSC# 732517) in Philadelphia
Chromosome Positive Acute Lymphoblastic Leukemia.
Purpose: To determine the feasibility and toxicity of an intensified chemotherapeutic regimen that incorporates dasatinib for treatment
of children, adolescents, and young adults (up to age 30) with Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic
Leukemia (ALL). To determine whether the intensification of tyrosine kinase inhibition through the addition of dasatinib in
Induction (Days 15-28) and substitution of dasatinib for imatinib during post-induction therapy, in the context of intensive
cytotoxic therapy (according to AALL0031) and a good early response to therapy, will lead to a 3-year event-free survival
(EFS) of at least 60% in patients with Ph+ ALL.
Eligibility Patients must be greater than or equal to 1 year and younger than or equal to 30 years of age at the time of being diagnosed
with Acute Lymphoblastic Leukemia (ALL) and be enrolled on COG AALL0232, AALL0331, AALL0434, or other frontline
COG ALL trial.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Acute Myeloid Leukemia
Title: COG 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.
Purpose: To determine the toxicities and tolerability of bortezomib in combination with standard relapse Acute Myeloid Leukemia
(AML) therapy in pediatric and young adult patients with relapsed or primary refractory or secondary AML. To estimate
the complete response rate to the Arm A and Arm B regimens.
Eligibility Patients between the ages of 12 months and 21 years old with a diagnosis of AML in relapse, or refractory state or a
secondary treatment related AML.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Acute Myeloid Leukemia
Title: COG AAML05P1: Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Stem Cell
Transplantation (SCT) for AML with Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute
Myelogenous Leukemia (AML) in Children: A Children's Oncology Group (COG) Study
Purpose: Treatment of Children with relapsed or refractory AML
Eligibility Greater than 1 month of age and less than 21 years of age with poorly responsive AML, relapsed AML, or high risk AML as
defined by cytogenetic features
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 160
Current Enrollment: 0
August 27, 2010
Adrenocortical Tumor
Title: Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy. (COG
ARAR0332)
Purpose: To describe the outcome of patients with Stage I adrenocortical tumors (ACT) who are treated with surgery alone. To
describe the outcome of patients with Stage II ACT who are treated with radical adrenalectomy plus regional retroperitoneal
lymph node dissection (RPLND). To describe the outcome of patients with unresected or metastatic adrenocortical carcinoma
who are treated with mitotane and a cisplatin-based chemotherapy regimen.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 2
Current Enrollment: 0
August 27, 2010
AML or Myelodysplastic Syndrome
Title: COG AAML0431: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and
Myelodysplastic Syndrome (MDS) Under the Age of 4 Years.
Purpose: To determine the event-free survival (EFS) and overall survival (OS) rates of Down syndrome (DS) children with Acute
Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) <4 years of age at diagnosis. To determine if the EFS rate
of DS AML patients aged <4 years at diagnosis can be increased compared to the EFS rate on COG A2971 with an
intensification of cytarabine (Ara-C) therapy during induction therapy. To determine if the number of intrathecal
chemotherapy treatments can be reduced in the treatment of DS AML patients <4 years of age at diagnosis. To determine if
the total cumulative anthracycline can be reduced in the treatment of DS AML patients <4 years of age at diagnosis.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 1
August 27, 2010
Extracranial Germ Cell Tumor
Title: A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell
Tumors. (COG AGCT0132)
Purpose: To avoid chemotherapy in low risk testicular/ovarian germ cell tumors by using surgery and observation, and using
chemotherapy only if the tumor returns. To decrease the total amount of chemotherapy given (3x instead of 4x) for those
patients receiving chemotherapy. To decrease the number of days over which the chemotherapy is given from 5 to 3 days.
To determine what genetic factors may be in malignant germ cell tumors and the blood of patients with these tumors.
Eligibility Male and female up to 21 years of age with ovarian or extragonadal primary tumores. Male patients up to 14 years of age
with testicular primary tumors. Tumors must be extracranial GCT that meet defined histologic criteria.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Gliomas
Title: A Phase II Study of Conformal Radiotherapy in Patients with Low-Grade Gliomas. (COG ACNS0221)
Purpose: To test the safety and effectiveness of this "small field radiation" in patients with low grade gliomas. To find out if the results
of a special test performed on the tumor tissue are related to the way the tumor responds to radiation.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Hepatoblastoma
Title: Phase III Intergroup Protocol for Treatment of Children with Hepatoblastoma. (COG P9645)
Purpose: To compare how effective two different chemotherapy regimens are in treating hepatoblastoma; to see if Amifostine can help
reduce the toxicity associated with some chemotherapy medicines used in treatment of hepatoblastoma; to test whether adding
Amifostine has any effect on the long term outcome of children treated for hepatoblastoma; to learn if children with Stage 1
pure fetal histology hepatobolastoma can be treated successfully with surgery alone; and to learn more about the biology of
hepatoblasoma so better treatments can be developed in the future.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 1
August 27, 2010
Hepatoblastoma
Title: COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma
Purpose: To show that a risk-based treatment approach will maintain or improve EFS, decrease acute and long-term chemotherapy
toxicity, and identify new agents for the treatment of children with Hepatoblastoma.
Eligibility Subjects must be less than or equal to 21 years of age at the time of diagnosis with any stage of Hepatoblastoma.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 210
Current Enrollment: 0
August 27, 2010
Hodgkin's Lymphoma
Title: COG AHOD0831 A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children with
Newly Diagnosed High Risk Hodgkin Lymphoma .
Purpose: Treatment of patients with high risk hodgkin disease.
Eligibility Paients between aged 0 - 21 years of age with high risk hodgkin disease.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 0
August 27, 2010
Hydroxyurea Therapy
Title: Pediatric Hydroxyurea Phase III Clinical Trial (BABYHUG) Follow-Up Observational Study.
Purpose: The main goal of the follow-up study is to study the long-term safety of HU. If treatment with HU provides a benefit or if a
safety problem is discovered, it will be important to determine if the age that HU was started is important. Follow-up of
children who participated in the BABYHUG study will provide us important information about whether HU treatment
should be given to infants and if so, the best age to begin treatment.
Eligibility All children who participated in the BABYHUG study are being asked to join the follow-up study whether or not their
parents choose for them to take HU from the pharmacy now or ever
Principal Investigator: Fixler, Jason M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 6
Current Enrollment: 4
August 27, 2010
Intermediate-Risk Neuroblastoma
Title: COG ANBL0531: Response and Biology-Based Therapy for Intermediate-Risk Neuroblastoma.
Purpose: To reduce therapy for patients with intermediate-risk neuroblastoma while maintaining a 3-year OS rate of equal to or greater
than 95% by using a response-based duration of therapy algorithm. To maintain an overall 3-year OS rate of equal to or
greater than 90% for patients within each Group (Stratum). To prospectively utilize loss of heterozygosity at 1p36 and
11q23 to refine risk-stratification and treatment assignment, allowing patients whose tumors lack these chromosomal
abnormalities to receive a reduction in therapy, and to compare the outcome with patients treated on A3961. To reduce
intensity of therapy for patients 365 to less than 547 days (12-18 months) of age with stage 4 neuroblastoma and favorable
biological features and to maintain a 3-year EFS rate consistent with that for patients less than one year of age with stage 4
neuroblastoma treated on A3961. To reduce intensity of therapy for patients 365 to less than 547 days (12-18 months) of
age with stage 3 MYCN-non amplified but unfavorable histology neuroblastoma, and to maintain a 3-year EFS rate consistent
with that for patients less than 365 days of age with stage 3, MYCN-non amplified, unfavorable histology neuroblastoma
treated on A3961. To reduce surgical morbidity for patients with stage 4S neuroblastoma by allowing for biopsy only, rather
than complete surgical resection, of the primary tumor. To systematically study the outcome of patients with stage 4S
neuroblastoma who are unable to undergo biopsy for biology-based assignment, and to evaluate the incidence of specific
baseline abnormalities in all patients with stage 4S neuroblastoma.
Eligibility Patients must be less than or equal to 12 years of age at the time of initial diagnosis. Enrollment on ANBL00B1 Is required
for all newly diagnosed patients within 21 days of the definitive diagnostic procedure, with the exception of infants with stage
4S neuroblastoma who are too ill to undergo a diagnostic biopsy procedure. Submission of the EDTA blood sample listed in
ANBL00B1 Is REQUIRED in order for the patient to be eligible for therapy reduction. Please call the contact person for
additional information.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 10
Current Enrollment: 1
August 27, 2010
Leukemia
Title: COG AAML0523: A Phase I/II Study of CLOLAR (Clofarabine IND# 73,789) in Combination with Dytarabine in Pediatric
Patients with Refractory/Relapsed Leukemia
Purpose: To find a safe dose of the drug clofarabine that can be given in combination with cytarabine without causing side effects that
are too severe. To find out how well a combination of the drugs clofarabine and cytarabine works against relapsed and
refractory leukemias.
Eligibility Patients between 1 and 30 years of age with refractory/relapsed leukemia. Must have adequate organ function and be
recovered from effects of previous therapy.
Principal Investigator: Wiley, Joseph M.
Phase: I/II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 87
Current Enrollment: 0
August 27, 2010
Leukemia
Title: COG 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 Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Purpose: To find out if bortezomib can be safely added to the standard COG Re-Induction therapy for relapsed ALL, and be an
effective therapy.
Eligibility Children and adolescents who have been treated in the past for lymphoblastic leukemia (ALL) or a cancer of tissue of the
immune system and has had a relapse.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 90
Current Enrollment: 0
August 27, 2010
Leukemia
Title: COG AAML0631: Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using
Arsenic Trioxide (Trisenox IND #103,331) During Consolidation.
Purpose: Treatment of newly diagnosed Acute Promyelocytic Leukemia.(APL). To test the effects of reducing the amount of
anthracycline chemotherapy and adding arsenic to standard APL treatment. To learn more about the biology and
characteristics of APL. To look for genetic changes in leukemia cells to learn more about APL and how to treat patients better.
To see if there is a connection between APL and obesity.
Eligibility Anyone ages 2 - 21 years of age with newly diagnosed Acute Promyelocytic Leukemia (APL).
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 86
Current Enrollment: 0
August 27, 2010
Low-Risk Embryonal/Botryoid Rhabdomyosarcoma
Title: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with
Newly Diagnosed Low-Risk Embryonal/Botryoid Rhabdomyosarcoma. (COG ARST0331)
Purpose: For subjects in subset 1 the goal is to see if lower doses of cyclophosphamide used together with current standard doses of
vincristine and dactinomycin can be as effective or better in curing patients as using the standard doses for vincristine and
dactinomycin and for subjects in subset 2 the goal is to see if lower doses of cyclophosphamide used together with current
standard doses of vincristine and dactinomycin can be as effective in curing patients as using the current standard doses of all
three drugs, and cause fewer late effects.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 1
August 27, 2010
Lymphoma/Leukemia
Title: COG 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.
Purpose: To determine the toxicity of the addition of Rituximab to Induction (COPADM [COMRAP]) and Consolidation
chemotherapy in children with newly diagnosed group B and group C leukemia/lymphoma treated with LMB/FAB therapy.
To assess the toxicity of Rasburicase added to COP (cyclophosphamide, vincristine, prednisone) [COP-R] Reduction phase
of LMB/FAB therapy in children with newly diagnosed group B and group C B-cell leukemia/lymphoma.
Eligibility Patients with newly diagnosed mature B-lineage Leukemia/Lymphoma by REAL Classification (diffuse large cell lymphoma,
burkitt's lymphoma, high grade b-cell lymphoma--buritt's like) who are greater than 1 year old and less than 30 years at the
time of study enrollment.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Malignant Germ Cell Tumors
Title: COG AGCT0521: Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors with Paclitaxel, Ifosfamide
and Carboplatin.
Purpose: To determine the response rates of recurrent or resistant germ cell tumors (GCT) to the combination of paclitaxel, ifosfamide,
and carboplatin (TIC). To describe the toxicity(ies) of the TIC regimen. To collect tissue for the tumor bank that will aid in
the identification of the biological characteristics of recurrent GCT.
Eligibility Patients must be less than 21 years of age at the time of original diagnosis of recurrent malignant or chemotherapy resistant
extracranial germ cell tumors. Tumors must contain one of the the following malignant elements: yolk sac tumor (endodermal
sinus tumor), choriocarcinoma, or embryonal carcinoma.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Nasopharyngeal Carcinoma
Title: Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy.
(COG ARAR0331)
Purpose: To see if a combination of chemotherapy followed by chemoradiotherapy works better at treating children with advanced
NPC than the standard therapy. To see how well amifostine protects children against dry mouth when given daily before
radiation therapy.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 2
Current Enrollment: 0
August 27, 2010
Neuroblastoma
Title: A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients with Neuroblastoma Associated
Opsoclonus-Myoclonus-Ataxia Syndrome Treated with Chemotherapy and Prednisone. (COG ANBL00P3)
Purpose: To determine if intravenous gammaglobulin therapy improves the motor coordination of children diagnosed with
neuroblastoma and presenting with opsoclonus-myoclonus-ataxia syndrome as assessed by neurological examination and
Vineland Adaptive Behavior Scale. To determine whether intervention with chemotherapy, steroids and IVIG improves the
functional outcome of children diagnosed with neuroblastoma and presenting with opsoclonus-myoclonus-ataxia syndrome
compared to historical controls.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Neuroblastoma
Title: COG ANBL0532: Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk
Neuroblastoma.
Purpose: To improve the 3-year event free survival (EFS) rate of high-risk neuroblastoma patients through treatment with a tandem
consolidation of Thiotepa/Cyclophosphamide followed by Carboplatin/Etoposide/Melphalan (CEM) as compared to single
CEM consolidation. To improve the rate of end-induction complete response and very good partial response, compared to
historical controls, by use of a topotecan-containing induction regimen. To improve the 3-year local control rate, compared to
historical controls, by increasing the local dose of radiation to the residual primary tumor for patients with less than a gross
total resection.
Eligibility Patients must be less than or equal to 30 years of age at the time of initial diagnosis of neuroblastoma or ganglioneuroblastoma
which has been verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary
catecholamine metabolites.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Neuroblastoma
Title: Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative
Therapy and Autologous Stem Cell Rescue. (COG ANBL0032)
Purpose: To compare two different treatments aimed at maintaining or improving patients' response to treatment on A3973.
Eligibility All patients must be diagnosed with neuroblastoma, and categorized as high risk at the time of diagnosis and must be less than
or equal to 30.99 years of age at diagnosis. All patients must have completed therapy including intensive induction followed
by ASCT and radiotherapy to be eligibile for the study.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 1
August 27, 2010
Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Title: Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS). (COG ARST0332)
Purpose: To define a risk-based treatment strategy for pediatric patients with non-rhabdomyosarcoma soft tissue sarcomas (NRSTS)
and to assess event-free and overall survival and the pattern of treatment failure in patients treated according to this strategy.
To assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- and high-risk NRSTS.
To assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in intermediate-and high-risk NRSTS
patients, and to determine which correlates best with clinical outcomes. To prospectively define clinical prognostic factors
associated with event-free survival, overall survival, local recurrence, and distant recurrence in pediatric patients with NRSTS.
To correlate patient outcomes observed in this study with findings of biologic studies performed on tissue specimens
collected from these patients on the D9902 study. To determine whether the diagnosis and histologic grade of NRSTS
assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology
reviewers.
Eligibility Patients less than 30 years at the time of the biopsy that established the diagnosis of Non-Rhabdomyosarcoma Soft Tissue
Sarcomas (NRSTS).
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Osteosarcoma
Title: COG 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: (IND 12697)
Purpose: In a randomized setting, to examine whether the addition of ifosfamide and etoposide (IE) to post-operative chemotherapy
with cisplatin, doxorubicin and methotrexate improves the event-free survival for patients with resectable osteosarcoma and a
poor histological response to 10 weeks of pre-operatiave chemotherapy. To also examine whether the addition of pegylated
interferon alfa-2b as maintenance therapy after post-operative chemotherapy with cisplatin, doxorubicin and methotrexate
improves the event-free survival for patients with resectable osteosarcoma and a good histological response to 10 weeks of
pre-operative chemotherapy.
Eligibility Patients must be between 5 and 40 years old on the date of diagnostic biopsy. Patients must have high grade osteosarcoma
which can include secondary malignancies.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 5
August 27, 2010
Rhabdomyosarcoma
Title: Intergroup Rhabdomyosarcoma Study Group Low-Risk Protocol. (COG D9602)
Purpose: To provide chemotherapy with the most effective and least toxic medications for patients with
rhabdomyosarcoma/undifferentiated sarcoma who have a low risk of recurrent disease.
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 1
August 27, 2010
Rhabdomyosarcoma
Title: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and
Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma. (COG ARST0531)
Purpose: To compare the early response rates, failure-free survival (FFS), and survival of patients with intermediate-risk RMS treated
with surgery, radiotherapy, and vincristine, dactinomycin and cyclophosphamide (VAC) or VAC alternating with vincristine
irinotecan (VI). To compare FFS, local control, and survival and patients with intermediate-risk RMS treated with VAC and
early (Week 4) radiotherapy compared to delayed (Week 10) radiotherapy, using IRS-IV for hisotric comparison.
Eligibility Patients less than 50 years of age who have been newly diagnosed with embryonal RMS, botryoid or spindle cell variants of
embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study. Enrollment on D9902 to confirm local
histologic diagnosis with central pathology review is required for all patients.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 1
August 27, 2010
Solid Tumor Malignancy
Title: COG 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.
Purpose: To find out if IMC-A12 can stop specific types of cancer from growing or cause it to get smaller, for a period of time, to learn
more about the side effects of IMC-A12, to learn more about the pharmacology (how the body handles the drug) of
IMC-A12, and to learn more about the biology of IMC-A12.
Eligibility Patients must be greater than 6 months and equal to or less than 30 years of age at study enrollment. They must have a
verified malignancy of eather osteosarcoma, ewing sarcoma/peripheral PNET, rhabdomyoscaroma, or neuroblastoma.
Principal Investigator: Wiley, Joseph M.
Phase: II
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 1
August 27, 2010
Stroke Sickle Cell
Title: Silent Cerebral Infarct Multi-Center Clinical Trial (SIT Trial)
Purpose: To test if blood transfusions can prevent strokes or silent infarcts in children with sickle cell anemia. Also to collect blood to
find out why children with sickle cell anemia have strokes or silent infarcts that change how sick the child might be.
Eligibility Patient must have sickle cell anemia (hemoglobin SS) or sickle beta thalassemia (hemoglobin sickle beta thalassemia) as
confirmed at the local institution by hemoglobin analysis after 6 months of age. Patient must be 5 through 14 years of age
(I.e., must have attained their 5th, but not their 15th birthday when the screening consent is signed) with no history of
strokes.
Principal Investigator: Fixler, Jason M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 40
Current Enrollment: 19
August 27, 2010
Wilms Tumor
Title: Treatment for Very Low, Low, and Standard Risk Favorable Histology Wilms Tumor. (COG AREN0532)
Purpose: Objectives for Very Low Risk Favorable Histology, Wilms Tumor is to demonstrate that very low risk patients treated by
nephrectomy and observation alone will have a 4 year Event Free Survival of greater than or equal to 85% and 4 year Overall
Survival greater than or equal to 95%; very low risk is defined Stage 1 favorable histology tumors of weight less than 550 g
with patient age less than 2 years at diagnosis. Objectives for Low Risk Favorable Histology, Wilms tumor is to demonstrate
that patients with a low risk of recurrence treated with vincristine and dactinomycin (Regimen EE4A) will have a 4 year Event
Free Survival of at least 90% and 4 year Overall Survival of at least 95%: low risk is defined as Stage 1 favorable histology
disease and either greater than or equal to 24 months of age at diagnosis or with tumor greater than or equal to 550g, and Stage
II favorable histology disease without Loss of Heterozygosity (LOH) of 1p and 16q. Objectives for Standard Risk Favorable
Histology, Wilms tumor is to document continued excellent outcome (4 year Event Free Survival greater than or equal to 85%
and Overall Survival greater than or equal to 95%) for patients with Stage III favorable histology Wilms Tumor without LOH
of 1p and 16q treated with vincristine, dactinomycin plus doxorubicin plus radiotherapy (Regimen DD4A).
Eligibility
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 2
August 27, 2010
Wilms Tumor
Title: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors. (COG AREN0533)
Purpose: To demonstrate that patients with Stage IV favorable histology (FH) Wilms tumor with pulmonary metastases only, who
have complete resolution of the pulmonary lesions after 6 weeks of DD4A chemotherapy (vincristine, dactinomycin, and
doxorubicin), called Rapid Complete Responders (RCR), will have at least an 85% 4 year event-free survival (EFS) after
therapy with additional DD4A and without whole lung irradiation. To demonstrate that Stage IV FH patients who do not
have resolution of pulmonary metastases by Week 6, called Slow Incomplete Responders (SIR), will have a 4 year EFS of
85% with the addition of cyclophosphamide and etoposide to a modified Regimen DD4A (Regimen M). To improve the 4
year EFS to 75% for patients with Stage III or IV FH Wilms Tumor with loss of heterozygosity (LOH) or chromosomes 1p
and 16q.
Eligibility Prior to enrollment in this study, all patients must have been enrolled on AREN03B2 for central pathology review. Stage III
patients with loss of heterozygosity (LOH) transferring from AREN0532 may be enrolled on this study.
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number: 5
Current Enrollment: 0
August 27, 2010
Wilms Tumor
Title: COG AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally Predisposed Unilateral Wilms Tumor
Purpose: To treat patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor.
Eligibility Patients <30 years old at the time of initial diagnosis with one of the following conditions:
1. Bilateral Wilms tumors or 2. Unilateral Wilms tumor and aniridia, Beckwith-Wiedemann Syndrome, idiopathic
hemihypertophy, Simpson-Golabi-Behmel Syndrome, Denys-Drash Syndrome or 3. Multicentric Wilms tumor or unilateral
Wilms tumor with contralateral nephrogenic rests in a child under one year of age or
4. Diffuse hyperplastic perilobar nephroblastomatosis or 5. Wilms tumor arising in a solitary kidney
Principal Investigator: Wiley, Joseph M.
Phase: III
For more information, contact: Entrup, Stephanie
Telephone Number: 410-601-8393
Email [email protected]
Approved Enrollment Number:
Current Enrollment: 0
August 27, 2010