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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.


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.


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


AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)

1 To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.

2.To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based Induction, additional doses of pegaspargase (PEG-ASP) during Induction and Delayed Intensification (DI), and dexamethasone pulses during Maintenance therapy

3. To determine if prophylactic cranial radiation therapy (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified asstandard or intermediate risk.

4.To determine the proportion of EOC MRD ? 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant
Similarly, to compare the EFS between very high risk (Induction failure) T-LLy
patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR).

5. To investigate the prognostic significance of Day 29 BM MRD in T-LLy patients.

6. To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL

7. To analyze and target relevant signaling pathways in T-ALL blasts, focusing on Early T cell Precursor ALL


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.


CA209238: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence.

* To compare the efficacy, as measured by recurrence free survival (RFS), provided by nivolumab versus ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV no evidence of disease (NED) melanoma who are at high risk for recurrence.

* To compare the overall survival of nivolumab vs. ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high risk for recurrence.

* To assess the overall safety and tolerability of nivolumab and ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high risk for recurrence.

* To evaluate whether PD-L1 expression is a predictive biomarker for RFS;

* To evaluate the Health Related Quality of Life (HRQoL) as assessed by European Orangization for Research and Treatment of Cancer (EORTC) QLQ-C30.


Gemtuzumab Ozogamicin Expanded Access Protocol For Treatment Of Patients In The United States With Relapsed/Refractory Acute Myelogenous Leukemia Who May Benefit From Treatment And Have No Access To Other Comparable/Aletrnative Therapy.

This expanded access protocol is designed in accordance with FDA 21 CFR 312.315
to allow compassionate access to Mylotarg for treatment of our single patient with AML who is thought to have the potential to derive clinical benefit and has exhausted other appropriate and reasonable treatment options. The objective of the protocol is to provide patients compassionate access to Mylotarg.
Therefore, there is no formal primary endpoint. Instead, safety information from
patients receiving Mylotarg in this setting will be carefully monitored, collected and


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-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


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 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-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 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).
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


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.


13-006: An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (asparaginase Erwinia chrysanthemi)/Erwinase® (crisantaspase)Administered Following Hypersensitivity to E. coli Asparaginase in Young Adults with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

1. The primary objective of this study is to determine the proportion of subjects with 2-day nadir serum asparaginase activity (NSAA) levels (48-hour levels taken after the 5th dose) that are >= 0.1 IU/mL in the first 2 consecutive weeks of Erwinaze treatment.
2.To determine the proportion of subjects with 3-day NSAA levels (72-hour levels taken after the 6th dose) that are ? 0.1 IU/mL in the first 2 consecutive weeks of Erwinaze treatment
3. To describe the NSAA over time following repeated administration of Erwinaze
4.To evaluate the safety of Erwinaze in young adult subjects as follows:
5.To describe the incidence and severity of asparaginase-related toxicities
6.To measure the presence of anti-Erwinaze antibodies and neutralizing antibody


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


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


TLC FIT: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors

The goal of this project is to develop and evaluate the feasibility of TLC FIT (Teens Living with Cancer Fitness Improvement Training), a technology-enhanced fitness program for adolescent and young adult (AYA) survivors of childhood cancers. Advances in treatment have fortunately led to a growth in the number of childhood cancer survivors in the US. Unfortunately, these survivors are at-risk for negative late effects from treatment, including cardiovascular disease and early death. Physical inactivity can exacerbate these risks. Adolescent survivors of childhood cancers in particular have reported significant declines in physical activity that persist following treatment. In preliminary work, we designed an eight-session group-based fitness program for AYA survivors using social cognitive theory. This program incorporated the FitBit, a novel commercially available electronic accelerometer, which allowed for self-monitoring of activity. The FitBit also provided an internet-based website for social networking among participants. The program was feasible and acceptable to participants, and they suggested lengthening the number of sessions to 12. Further, participants reported low levels of engagement with the FitBit website and a strong interest in on-the-go access to program materials outside of weekly group sessions. Therefore, the next step is to significantly enhance the technology by creating a cancer-specific smartphone application (app) that motivates participants to engage in and sustain behavior change. Phase 1 of this project involves the development of the mobile app. Following app development and validation, in Phase 2 we will conduct a randomized pilot trial (n = 88) of TLC FIT to evaluate feasibility and effectiveness.


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.