Adolescent and Young Adult Clinical Trials

A Phase II Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Age - Patients must be Greater than or Equal to 3 Years and Less than 22 Years of Age at the Time of Enrollment on ACNS1422 Step 0.

A Phase II Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)

Patients must be ≥ 3 Years and ≤ 25 Years of Age at the Time of Enrollment on Step 0.

Note: The HGG Pre-Enrollment Eligibility Screening (Step 0) has been paused until further notice.

A Phase III Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in 
Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Patients must be ≥ 2 Years and ≤ 21 Years at the Time of Enrollment.

ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Patients must be ≥ 2 years and ≤ 21 years of age at the time of enrollment on ACNS1833 Step 0.

Neuroblastoma Biology Studies

All Newly Diagnosed Patients with Suspected Neuroblastoma, Suspected Ganglioneuroblastoma, or Suspected Ganglioneuroma/Maturing Subtype Seen at COG Institutions are Eligible for this Study. 

COG-ACNS1931: A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

Feasibility Phase - Patients must be ≥ 2 years and ≤ 21 years of age at the time of enrollment.
Efficacy Phase: Patients must be ≥ 2 years and ≤ 25 years of age at the time of enrollment.
All patients > 21 years of age at the time of enrollment must have had initial diagnosis of low-grade glioma by 21 years of age.

COG ACNS2021

A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Patients must be greater than or equal to 3 years and less than 30 years at the time of study enrollment.

COG ACNS1821: A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

Patients must be ≥ 12 months and ≤ 21 years of age at the time of enrollment.

Step 1 enrollment is temporarily closed to accrual. 

COG-ACNS2031: A Phase 3 Study of Sodium Thiosulfate for the Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy for Children with Medulloblastoma with Low-Risk Features

Age: ≥ 4 years and ≤ 21 years of age at the time of enrollment

Key Adverse Events After Childhood Cancer

Diagnosis of Primary Cancer at Age 21 or Younger, Irrespective of Current Age.

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Age: Patients must be ≤ 30 Years of Age at the Time of Diagnosis

As of June 30, 2022, AHEP1531 Group D is temporarily closed to accrual.

A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors

Renal Tumors Classification, Biology, and Banking Study 

Patients must be < 30 Years Old at the Time of Diagnosis

COG-AREN1921: Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Patients must be ≤ 30 years old at study enrollment.

A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors

A Phase III Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

Age:

Low Risk Stratum (Stage I Ovarian Immature Teratoma and Stage I Malignant GCT (all sites))
Patients must be < 50 Years of Age at Enrollment.

Standard Risk 1
Patient must be < 11 Years of Age at Enrollment.

Standard Risk 2 & AYA-HEARS
Patients must be ≥ 11 and < 25 Years of Age at Enrollment. 

Phase III Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Age ≥ 11 Years and ≤ 45 Years on the Date of Randomization

COG ACNS2021

A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Patients must be greater than or equal to 3 years and less than 30 years at the time of study enrollment.

COG-ASCT2031: A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS)

Age: 6 months to <22 years at enrollment

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

A Phase II Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Patients must be ≥1 Year and < 22 Years of Age at the Time of Enrollment.

AALL1621 has been temporarily closed to accrual as of March 8, 2022, pending an evaluation of patients currently enrolled on this study.

International Phase III Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Age:  > 1 Year and < 21 Years at ALL Diagnosis

A Phase III Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

Patients must be ≥ 365 Days and < 10 Years of Age (B-ALL Patients without DS)

Patients must be ≥ 365 Days and ≤ 31 Years of Age (B-ALL Patients with DS)

Patients must be ≥ 365 Days and ≤ 31 Years of Age (B-LLy Patients with or without DS

Temporary Closure to Accrual as of 12/19/2022

A Phase III Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518)for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL,Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Patients must be > 365 Days and < 25 Years of Age

COG AALL1821

A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse

Temporary Closure to Accrual as of 12/19/2022

COG AAML18P1

Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Patient must have been diagnosed with CML-CP at less than 18 years of age

Patient mustbe less than 25 years of age at enrollment

COG-AAML1831: A phase 3 randomized trial for patients with de novo AML comparing standard therapy including gemtuzumab ozogamicin GO to CPX-351 with GO, and the addition of the FLT3 inhibitor gilteritinib for patients with FLT3 mutations

Patients must be less than 22 years of age at the time of study enrollment.

As of June 14th, 2022, Arms C and D (AC, BC, AD, BD) in protocol AAML1831 are temporarily closed to accrual

COG APAL2020SC

Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias

Patients must be less than 22 years of age at the time of study enrollment.

COG ANHL1931

A Randomized Phase 3 trial of Nivolumab (NSC#748726 IND#125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

This is an AYA protocol  ≥ 2 years

ALTE2031 - StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention among Adolescent and Young Adult Childhood Cancer Survivors

Patient must be ≥15 years and < 21 years at the time of enrollment.

A Phase III Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors

Age:

Low Risk Stratum (Stage I Ovarian Immature Teratoma and Stage I Malignant GCT (all sites))
Patients must be < 50 Years of Age at Enrollment.

Standard Risk 1
Patient must be < 11 Years of Age at Enrollment.

Standard Risk 2 & AYA-HEARS
Patients must be ≥ 11 and < 25 Years of Age at Enrollment. 

The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

Subjects must be ≤ 25 Years of Age at Time of Original Diagnosis, except for Patients who are being Screened Specifically for Eligibility onto a COG (or COG Participating NCTN) Therapeutic Study, for whom there is a Higher Upper Age Limit.

Key Adverse Events After Childhood Cancer

Diagnosis of Primary Cancer at Age 21 or Younger, Irrespective of Current Age.

Umbrella Long-Term Follow-Up Protocol

Only Available to Patients Already Enrolled on a COG Intervention Protocol.

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase II subprotocol of LOXO-101 (larotrectinib) in patients with tumors harboring actionable NTRK fusions.

Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment.

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase II subprotocol of LY3023414 in Solid Tumors

Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment.

COG APEC1621F

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase II subprotocol of Ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations

Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment.

APEC1621K - NCI-COG Pediatric Molecular Analysis for Therapy Choice MATCH - Phase 2 Subprotocol of AG-120 (Ivosidenib) in Patients with Tumors Harboring IDH1 Mutations

Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment.

APEC1621M: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of Tipifarnib in patients with tumors harboring HRAS genomic alterations

Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment.

APEC1621N: NCI-COG Pediatric Molecular Analysis for Therapy Choice (MATCH) – Phase 2 Subprotocol of LOXO-292 in Patients Harboring RET Gene Alterations

Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment.

COG-ACCL21C2: Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults with Cancer

≥6 months and ≤37 years of age at time of enrollment

COG-ANHL2121: Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis

Age: 180 days- <22 years (at time of study enrollment).

Neuroblastoma Biology Studies

All Newly Diagnosed Patients with Suspected Neuroblastoma, Suspected Ganglioneuroblastoma, or Suspected Ganglioneuroma/Maturing Subtype Seen at COG Institutions are Eligible for this Study. 

A Phase III Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Age - Patient must be ≥ 365 Days and ≤ 30 Years of Age at Diagnosis.

ARM C perm closed

A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

Patients ≥ 1 year of age at the time of enrollment are eligible for this study.

Temporary Closed to Accrual as of March 06, 2023

COG ARST2031

A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)

Patients must be ≤ 50 years of age at the time of enrollment.

COG-AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma 

Patients must be < 40 years of age at the time of enrollment.

COG- ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Patients must be ≤ 21 years at the time of enrollment.

COG AOST2031

A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma

Patients must be < 50 years at the time of enrollment