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ProtocolTrial Name and Objective
091405

Request for Single Patient Use of MSB0010718C in a 10 Year-Old Patient with Merkel Cell Carcinoma

The primary objective of the trial is to assess the clinical activity of MSB0010718C in subjects with metastatic Merkel cell carcinoma (MCC) as determined by the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by an Independent Endpoint Review Committee (IERC).

Secondary objectives are as follows:
To assess the duration of response according to RECIST 1.1
To assess the progression-free survival time (PFS) according to RECIST 1.1
To assess the safety profile of MSB0010718C in subjects with MCC
To assess the overall survival (OS) time

Exploratory objectives are as follows:
To characterize the pharmacokinetic (PK) profile of MSB0010718C
To evaluate the immunogenicity of MSB0010718C and to correlate it to exposure and biological activity
To assess the immune-related best overall response (irBOR) and immune-related PFS (irPFS) using the modified immune-related response criteria (irRC), derived from RECIST 1.1
To evaluate changes in biomarkers in relation to disease responses to MSB0010718C
To evaluate the association between tumor programmed death ligand 1 (PD-L1) expression and best overall response (BOR)
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131213

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.
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130503

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.
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001209

Targeted Genomic Analysis of Human Cancers

The purpose of this study is to identify potentially "actionable" genomic alterations in cancers using next-generation sequencing technology, with a focus on rare cancers and cancers for which there is limited standard therapy. The overall hypothesis of this protocol is that actionable mutations are present in a significant subset of patients with cancers for which there is no effective curative therapy. To test this hypothesis, the aims of this study are as follows:

1.1. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies.
1.2. To collect clinical outcomes of patients for which sequencing has been performed.
1.3. To obtain whole tumor genome data for data storage and future computational analysis and correlation with clinical data.
1.4. To obtain tumor tissue for development of future in vitro and in vivo cancer models.
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110811

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.
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110907

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.
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111003

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.
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111007

COG-AALL0932: Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

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
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111011

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.
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011104

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.
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111109

COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma

1.1.2
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).

1.1.3
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.

1.1.4
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.

1.1.5
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

1.2.1
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.

1.2.2
To determine the feasibility and toxicity of adding doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.

1.2.3
To estimate the response rate to vincristine and irinotecan in previously untreated children with high-risk, metastatic hepatoblastoma.

1.2.4
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.

1.2.5
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.
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111104

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.
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111301

COG-ANBL1221: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 764038, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma

1. To determine if the addition of a molecularly
targeted anti-cancer agent (temsirolimus or ch14.18) to the chemotherapy backbone of irinotecan and temozolomide will be tolerable and will result in improved response rates in
patients with refractory, relapsed or progressive
neuroblastoma.

2. To identify whether temsirolimus or ch14.18 is the optimal therapeutic agent to consider for
further testing in a future Phase III randomized trial for treatment of newly diagnosed high risk
neuroblastoma.

3. To compare the response rates (RR) for patients receiving temsirolimus or ch14.18 in
combination with irinotecan and temozolomide

4. To compare the progression free survival and overall survival rates for patients
receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide

5. To compare the toxicities associated with temsirolimus or ch14.18 when combined with
irinotecan and temozolomide in patients with
refractory, relapsed or progressive neuroblastoma

6. To compare the ability to maintain intended dose intensity of all agents when temsirolimus or
ch14.18 is combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma

7. To determine the concordance between tumor responses as defined by standard International
Neuroblastoma Response Criteria (INRC) versus response per the revised INRC.

8. To study the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 antibody
.
9. To study the clinical relevance of NK receptor NKp30 isoforms in patients receiving ch14.18 antibody or temsirolimus
.
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111204

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
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111205

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
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111208

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
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111304

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
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111305

COG ANHL12P1 A Randomized Phase II study of Brentuximab Vedotin (NSC# 749710) and Crizotinib (NSC# 749005) in Patients with Newly Diagnosed Anaplastic Large Cell Lymphoma (ALCL) IND #117117

1. To determine the
tolerability of brentuximab vedotin given in combination with
standard chemotherapy (ALCL99) and to determine the tolerability of crizotinib
given in combination with chemotherapy (ALCL99).
2.
To estimate the Event Free Survival of Arm Brentuximab and standard chemotheray and Crizotinib and standard chemotherapy and contrast these to historical control data.

3. To determine the prognostic significance of minimal disseminated
disease (MDD) at diagnosis and minimal residual disease (MRD)
as measured by RT - polymerase chain reaction (PCR)in peripheral blood
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111406

Childrens Oncology Group-ANBL1232 Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma

1.To eliminate therapy as the initial approach for infants < 12 months of age with small INRG Stage L1 neuroblastoma while maintaining an overall survival (OS) of 99%.
2.To eliminate therapy as the initial approach for non-high-risk patients < 18 months of age with localized neuroblastoma and favorable biology (histologic and
genomic features) while maintaining an OS of 99%.
3.To achieve a 3-year OS of > 81% for infants < 18 months of age with INRG Stage
Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm.
4.To describe the time to intervention or tumor progression, type of intervention and site of progression for patients with localized neuroblastoma who experience
progression after an initial period of observation.
5. To characterize the pharmacokinetic profile of the chemotherapeutic agents
carboplatin and etoposide in patients with Stage Ms disease.
6.To define the genomic profile of tumors from patients with non-high-risk
neuroblastoma both at initial biopsy and at the time of subsequent biopsy or surgical resection.
7.To describe the histology of tumor specimens obtained at the time of subsequent biopsy or surgical resection.
8.To determine the salvage rate (OS) of patients with tumor relapse or disease progression.
9.To determine the procedural complication rate (initial biopsy, resection [intraoperative and postoperative], subsequent biopsy) and correlate with the
degree of surgical resection.
10.To determine the rate of reduction in image defined risk factors (IDRF) in L2 tumors following observation or chemotherapy
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111401

COG ACNS1221: A Phase II Study for the Treatment of Non-Metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age

1. Estimate of the PFS distribution for patients 0-<4 years of age with M0 desmoplastic medulloblastoma (nodular desmoplastic or medulloblastoma with extensive nodularity) treated with the modified HIT SKK regimen (excluding the use of intraventricular methotrexate).
2.Evaluate the feasibility of a rapid central pathology screening review for treatment allocation according to histology and assess agreement between institutional and central pathology review diagnoses as well as among central pathology review diagnoses.

3.Prospectively evaluate the molecular profile of ND/MBEN medulloblastoma in young children.

4. Monitor and describe the neurocognitive and adaptive functioning of young children with ND/MBEN medulloblastoma treated on this protocol using the ALTE07C1 protocol.
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111410

COG-ACNS0821 - Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial

1.To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan and bevacizumab for recurrent medulloblastoma (MB)/PNET of childhood.
2.To assess the response rate for each treatment arm amongst patients who are enrolled with measurable disease.
3. To determine event-free survival (EFS) for each patient compared across regimens.
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111102

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
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001402

Proleukin® Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

Primary Objective
To establish an observational data to report and query on
Patient care patterns
* Clinical outcomes and trends from HD IL-2 therapy
in treating patients with mM, mRCC or other malignancies
Secondary Objectives
To evaluate patient/site specific prognostics and treatment emergent
outcomes associated with HD IL-2
To publish real-world practices of IL-2 immunotherapy on annual basis
To maintain an expandable database platform for future research interest
and projects relevant to IL-2 in mM and mRCC or other malignancies
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031007

Asymmetric Cell Division and Notch Signaling in Lung Cancer Stem Cells

To determine if Notch signaling, chemokine signaling and epithelial-mesenchymal transition, or interactions between these pathways, regulate self-renewal of lung cancer stem cells.
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