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ProtocolTrial Name and Objective

Environmental Determinants of Puberty. A Pilot Study

To test the feasibility of conducting a cohort study of prepubertal girls in New Jersey and allow us to learn essential information for the planning of such future study.


Sun Protection and Skin Surveillance: Beliefs and Behaviors of Childhood Cancer Survivors

To establish the prevalence and correlates of skin cancer prevention and surveillance behaviors among CCS using depth interviews and survey research.


COG-AALL0631: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC #617807)

We want to find out if adding lestaurtinib to standard therapy for Intermediate and High Risk infants with ALL will result in better treatment outcomes than standard chemotherapy alone. Since lestaurtinib only targets leukemia cells, it is hoped that the side effects of lestaurtinib will be less than for standard chemotherapy drugs. Although lestaurtinib is investigational and has not been approved by the FDA, it has been shown to be well-tolerated in children and adults. The side effects of lestaurtinib in infants are not known because the drug hasn't been evaluated in infants yet.

The goal of Part 1 of the study is to find the dose of lestaurtinib that is safe and that can turn off the FLT3 gene when given to Intermediate and High Risk infants with ALL.

During Part 1 of the study, lestaurtinib will be given to Intermediate and High Risk patients only at a limited number of cancer treatment centers. The Cancer Institute of New Jersey is NOT one of these centers. Therefore subjects will receive the combination chemotherapy treatment without lestaurtinib.

Part 2 of this study will only be undertaken if Part 1 of the study successfully finds a dose of lestaurtinib that is safe and can turn off the FLT3 gene. In Part 2 of the study, the researchers will try to find out how helpful lestaurtinib is in getting rid of cancer in infants with Intermediate and High Risk. Subjects participating in Part 1 of the study will not participate in Part 2 of the study.

The goal of Part 2 of the study is to find out the effects, good and/or bad, of lestaurtinib given in combination with standard chemotherapy in treating Intermediate and High Risk infants with ALL.


COG-AREN0534: Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor: A Groupwide Phase III Study

1. To improve 4 year event-free survival (EFS) to 73% for patients with bilateral Wilms tumor (BWT).
2. To prevent complete removal of at least one kidney in 50% of patients with BWT by using 3-drug chemotherapy induction with vincristine, dactinomycin and doxorubicin, prior to kidney surgery.
3. To evaluate the efficacy of chemotherapy in preserving normal kidney tissue in children with diffuse hyperplastic perilobar nephrogenic rests (DHPLNR) and preventing Wilms tumor development.
4.To facilitate partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin.
5. To have 75% of children with BWT undergo definitive surgical treatment by 12 weeks after initiation of chemotherapy.


COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

1. To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy with vincristine, cisplatin, etoposide and cyclophosphamide (VCEC).

2. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by a) post-operative induction chemotherapy or by b) second surgery who will then be non-randomly assigned to cRT followed by four cycles of maintenance chemotherapy (VCEC)

3. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection or children who achieve a CR to short course induction chemotherapy following first surgery.


COG-AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) A Groupwide Phase III Study

1.To determine if a Maintenance regimen containing weekly oral methotrexate at 40 mg/m2/week will result in an improved disease free survival compared to that containing weekly oral methotrexate at 20 mg/m2/week in the average risk subset of patients with Standard Risk B-precursor ALL.
2. To determine whether a reduced-pulses Maintenance regimen with vincristine/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the average risk subset of patients with Standard Risk B-precursor ALL.
3.To confirm that patients in the low risk subset of Standard Risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5-year DFS of at least 95%
with either a P9904-based regimen that includes 6 courses of intermediate dose (1 g/m2 over 24 hours) methotrexate without alkylating agents or anthracyclines or an outpatient based regimen identical to that of average risk patients with vincristine/dexamethasone pulses at 12 week intervals during maintenance


COG AEWS1031: A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma

To test the effect of a combination of vincristine, cyclophosphamide and topotecan added to the standard 5-drug chemotherapy interval compressed backbone on event-free and overall survival in children and young adults with Ewing Sarcoma.


NMDP 10-CBA: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Primary: to examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.


COG-AAML1031: 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

1. To compare event free survival (EFS) and overall survival (OS) in patients with de novo acute myeloid leukemia (AML) without high allelic ratio FLT3/ITD+ mutations who are randomized to standard therapy versus bortezomib/standard combination therapy.
2, To determine the feasibility of combining bortezomib with standard chemotherapy in patients with de novo AML.
3. To compare the OS and EFS of high risk patients treated with intensive Induction II with historical controls from AAML03P1 and AAML0531. 1.1.4 To determine the feasibility of combining sorafenib with standard chemotherapy in patients with de novo high allelic ratio FLT3/ITD+ AML.
4. Secondary Objectives 1.2.1 To assess the anti-leukemic activity of sorafenib in patients with de novo high allelic ratio FLT3/ITD+ AML. 1.2.2 To compare the percentage of patients converting from positive MRD to negative MRD after Intensive Induction II with historical controls from AAML03P1 and AAML0531.
5. To compare OS, disease free survival (DFS), cumulative incidence of relapse, and treatment related mortality from end of Intensification I between patients allocated to best allogenic donor stem cell transplant (SCT) and comparable patients on AAML0531 who did not receive allogenic donor SCT.
6. To compare OS, DFS, cumulative incidence of relapse, treatment related mortality, and severe toxicity between patients allocated to matched family donor SCT on AAML1031 and AAML0531. 1.2.5 To assess the health-related quality of life (HRQOL) of patients treated with chemotherapy and stem cell transplant (SCT) for AML.
7. To compare the changes in shortening fraction/ejection fraction over time between patients treated with and without dexrazoxane.
8. To refine the use of minimal residual disease (MRD) detection with 4-color flow cytometry.


COG-AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum

1. To determine if the administration of post induction age adjusted intrathecal (IT) triple therapy on an MBFM-IMHDM backbone wlll improve 5 year survival when compared to IT MTX
2. To determine in a randomized fashion if the cyclophosphamide + etoposide containing regimen (Experimental Arm 1) or the clofarabine + cyclophosphamide + etoposide combination regimen (Experimental Arm 2) will improve the 4 year DFS of children, adolescents and young adults with Very high risk ALL compared to a modified MBFM-IMHDM regimen that contains a second interim maintenance (Control Arm).
3. To determine, in a randomized fashion, if the cyclophosphamide + etoposide + clofarabine containing combination regimen (Experimental Arm 2) will improve the 4-year DFS of children, adolescents, and young adults with VHR-ALL compared to the cyclophosphamide + etoposide combination regimen (Experimental Arm 1).


COG AALL1122: A Phase 2 Multi-Center, Historically-Controlled Study of Dasatinib (IND# 66,971) Added to Standard Chemotherapy in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

1. To Compare the 3 year survival of historical chemotherapy to dasatinib + chemotherapy
2. To determine safety and efficacy of adding dasatinib to chemotherapy regimens for leukemia
3. To determine effect of dasatinib on MRD levels in pediatric patients with Philadelphia Positive Acute Lymphoblastic Leukemia


COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma

Stage I hepatoblastoma (non-pure fetal histology [PFH]), non-small cell undifferentiated [SCU]) and Stage II (non-SCU) is a highly curable disease with 2 cycles of adjuvant cisplatin, 5-fluorouracil, and vincristine (C5V).

The addition of doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma will be feasible and associated with acceptable levels of toxicity.

The use of vincristine and irinotecan in an upfront window for children with high-risk, metastatic hepatoblastoma will improve the response rate in this group of children.

Referral for orthotopic liver transplant (OTL) is feasible in a cooperative group setting in children with hepatoblastoma designated as potentially unresectable following central surgical review and staging according to the PRE TEXT (Pretreatment Extent of Disease) grouping system.

1.2 Primary Aims

To estimate the EFS in children with Stage I (non-PFH, non-SCU) and Stage II (non SCU) hepatoblastoma treated with surgical resection followed by 2 cycles of C5V.

To determine the feasibility and toxicity of adding doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.

To estimate the response rate to vincristine and irinotecan in previously untreated children with high-risk, metastatic hepatoblastoma.

To determine whether timely (between diagnosis and end of second cycle of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma.

To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials.


COG 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

1. To determine if treatment of infants with high risk PNET CNS tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell rescue results in a higher complete response rate than the same regimen without methotrexate
2. To determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors from primitive neuroectodermal tumors and possibly identifying other markers of value for stratification within the group of peripheral neuroectodermal
3. To determine if event free survival and patterns of failure differ between the methotrexate arm and the arm without methotrexate.
4. To compare acute, chronic and late effects of different regimens
5. To compare quality of life outcomes


COG ACNS1022: A Phase II Randomized Trial of Lenalidomide (NSC # 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

1. To determine the objective response rate of children with recurrent, refractory or progressive juvenile astrocytomas and optic pathway gliomas who are treated with low-dose (20 mg/m2/dose) or high dose (115 mg/m2/dose) lenalidomide.
2. To estimate the event free survival of these patients when treated with lenalidomide
3. To correlate pharmacokinetics with objective response
4. To evaluate toxicities of long term lenalinomide use


COG-ANHL1131: Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma (NHL) or Mature B-cell Leukemia (B-AL): Evaluation of Rituximab Efficacy and Safety in High Risk Patients

1. For patients with advanced stage B-Cell NHL/B-AL to test whether adding 6 injections of rituximab to standard LMB therapy increases the event free survival
2. For patients with PMLB, to evaluate the event free survival following treatment with DA-EPOCH-rituximab
3. To evaluate potential diagnostic value of MRD in this population
4. To obtain data on PET scans in childhood Bcell NHL
5. To characterize pharmacokinetics of rituximab in combination with LMB therapy


COG ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

To determine if monoclonal antibody + cytokines + isotretinoin improves event free survival after myeloablative therapy and stem cell rescue

To determine whether tumor biology at diagnosis correlates with event free survival

Determine toxicities of chimeric antibody


COG ACCL0934:A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

1. To determine if levofloxacin given prophylactically during periods of neutropenia to patients being treated for AL or undergoing SCT will decrease the incidence of bacteremia

2. To determine the effect of prophylaxis on the incidence of F+N, severe infection and death from bacterial infection

3. Assess safety, with specific focus on musculoskeletal disorders

4. Assess impact on bacterial resistance


COG: ANBL12P1 Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High Risk Neuroblastoma: A Groupwide Pilot Study

1.To determine if the acute toxicity of an autologous stem cell transplant with a busulfan/melphalan (BuMel) based regimen is tolerable when given as
Consolidation therapy for high-risk neuroblastoma.

2.To determine the incidence of non-hematologic organ toxicity (Grade 3 and higher) and all causes of mortality in patients undergoing autologous stem cell transplant with a BuMel based regimen followed by local radiotherapy for the treatment of high-risk neuroblastoma.

3. To describe response rates, event-free survival (EFS), and overall survival (OS) for patients undergoing Induction therapy followed by Consolidation with myeloablative BuMel preparative regimen and local radiotherapy for the treatment of high-risk neuroblastoma.

4.To correlate busulfan pharmacokinetics with non-
hematologic toxicity following a BuMel based autologous transplant regimen
and event-free survival and overall survival

5.To determine the feasibility of performing Curie scores in real time, as assessed by central scan committee review of a 123 I-MIBG scan obtained after Cycle 4 of Induction therapy.

6. To examine the concordance between central reviewers and institutional reviewers in performing Curie scoring at diagnosis and after Cycle 4 of Induction therapy.

7. To determine the feasibility of detecting aberrations in the Anaplastic Lymphoma Kinase (ALK)gene in tumors obtained at the time of diagnosis in patients with high-risk neuroblastoma.

8.To determine the feasibility of performing molecular profiling of neuroblastoma tumors obtained at the time of diagnosis in patients with high
-risk neuroblastoma.

9. To correlate melphalan pharmacokinetics with non-hematologic toxicity following a BuMelbased autologous transplant regimenand event-
free survival and overall survival


COG ACCL0933: A Randomized Open Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

To determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia is associated with a lower incidence of proven or probable invasive fungal infections compared with fluconazole.

To determine sensistivity, specificity of biweekly galactomannan and beta-D glucan testing

To test association between single nucleotode polymorphisms in genes involved in innate immunity