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 Veliparib (ABT-888, IND # 139199) and Local Irradiation,Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations

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

Patients >21 Years must be IDH Mutant.

Note: At the time of ACNS1721 Step 1 enrollment, patients will be stratified and age is a factor.

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.

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. 

Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult AYA Acute Lymphoblastic Leukemia ALL

Key Adverse Events After Childhood Cancer

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

Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult AYA Acute Lymphoblastic Leukemia ALL

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

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

Renal Tumors Classification, Biology, and Banking Study 

TEMPORARY CLOSURE

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

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:

1. Low Risk Stratum (Stage I Ovarian Immature Teratoma and Stage I Malignant GCT (all sites))
   Patients must be < 50 Years of Age at Enrollment.
2. Standard Risk 1
   Patient must be < 11 Years of Age at Enrollment.
3. Standard Risk 2
   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-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.

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)

TEMPORARY CLOSURE

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

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia

Age ≥ 1 Year and ≤ 21 Years at Time of Leukemia Diagnosis.

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

Documentation and Delivery of Guideline-Consistent Treatment in Adolescent and Young Adult AYA Acute Lymphoblastic Leukemia ALL

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)

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

A Randomized Phase II Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL) TEMPORARY CLOSURE

Patient must be < 22 Years of Age.

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase II subprotocol of JNJ-42756493 (Erdafitinib) in patients with tumors harboring FGFR1/2/3/4 alterations.

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 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 tazemetostat for patients with tumors harboring alterations in EZH2 or members of the SWI/SNF complex TEMPORARY CLOSURE

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.

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.

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase II subprotocol of olaparib in patients with tumors harboring defects in DNA damage repair genes

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 Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes

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 BVD-523FB (ulixertinib) in Patients with Tumors Harboring Activating MAPK Pathway Mutations dated 11/26/2019

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) Screening Protocol

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.

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase II subprotocol of Vemurafenib in patients with tumors harboring actionable BRAF V600 mutations

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

1. Low Risk Stratum (Stage I Ovarian Immature Teratoma and Stage I Malignant GCT (all sites))
   Patients must be < 50 Years of Age at Enrollment.
2. Standard Risk 1
   Patient must be < 11 Years of Age at Enrollment.
3. Standard Risk 2
   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.

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.

A Randomized Phase III Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Feasibility Phase: Patients must be < 21 Years of Age at the Time of Enrollment.
Efficacy Phase: Patients must be ≤ 40 Years of Age at the Time of Enrollment.

Effects of Modern Chemotherapy Regimens on  spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Patients must be ≥ 18 and ≤ 50 Years of Age at the Time of Enrollment