Clinical Trials Actively Recruiting Children and Young Adults With Cancer

Study Type: Observational

Study Title: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN) Children’s Oncology Group

Study Sponsor and Collaborators: National Cancer Institute

Purpose: The goal of the CCRN is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada so researchers can study patterns, characteristics, and causes of childhood cancer.

Ages Eligible for Study: up to 18 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To collect information on children with cancer (time frame: after initial diagnosis)

Principal Investigator: Crystal L. Mackall, MD, National Cancer Institute; 301-402-5940, mackallc@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01117168

Study Title: A Pilot Trial Testing the Feasibility of Using Molecular Profiling to Guide an Individualized Treatment Plan in Children and Young Adults With Newly Diagnosed DIPG (Diffuse Intrinsic Pontine Glioma)

Study Sponsor and Collaborators: University of California, San Francisco; Translational Genomics Research Institute

Purpose: To test a new treatment approach based on each patient’s tumor genomic profiling consisting of whole exome sequencing and RNA sequencing as well as predictive modeling

Ages Eligible for Study: up to 25 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Number of patients for whom an individualized treatment plan is provided within 21 business days (time frame: within 21 business days of tumor tissue collection)

Principal Investigator: Sabine Mueller, MD, UCSF Helen Diller Family Comprehensive Cancer Center; muellers@neuropeds.ucsf.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02274987

Study Title: A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: To evaluate the impact of adding a focused physical therapy intervention to the preoperative regimen of individuals diagnosed with a malignancy of the lower extremity

Ages Eligible for Study: 6 to 30 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Feasibility of a 10-week physical therapy intervention program (time frame: up to 12 weeks postsurgery)

Principal Investigator: Angela M. Corr, PT, DPT, St. Jude Children’s Research Hospital; 866-278-5833, angela.corr@stjude.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01674101

Study Title: Childhood Cancer Survivor Study

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital; National Cancer Institute; Fred Hutchinson Cancer Research Center; Nationwide Children’s Hospital; The University of Texas MD Anderson Cancer Center; University of Southern California; Children’s Hospital Medical Center, Cincinnati

Purpose: To investigate the long-term effects of cancer and its associated therapies

Ages Eligible for Study: Cancer survivors diagnosed at ages 21 and younger

Genders Eligible for Study: Both

Accepts Health Volunteers: Yes

Primary Outcome Measures: To characterize survivors’ health outcomes with respect to disease-, treatment, and genetic-related factors (time frame: 25 years)

Principal Investigator: Gregory T. Armstrong, MD, MSCE, St. Jude Children’s Research Hospital; 866-278-5833, inmfo@st.jude.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01120353

Study Type: Phase I/interventional/nonrandomized

Study Title: A Phase I Trial of Autologous T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center; Dana-Farber Cancer Institute; Dana-Farber Children’s Hospital

Purpose: To test the safety of giving patients modified T cells after their leukemia has returned to the bone marrow

Ages Eligible for Study: up to 26 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Safety of gene-modified autologous T cells targeted to CD19 and infused into patients with relapsed/refractory B-cell ALL. Toxicities that are related to treatment will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events, version 4.0 (time frame: 1 year).

Principal Investigator: Kevin Curren, MD, Memorial Sloan Kettering Cancer Center; 212-639-5836

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01860937

Study Title: Imiquimod/BTIC Lysate-Based Vaccine Immunotherapy for Diffuse Intrinsic Pontine Glioma in Children and Young Adults

Study Sponsor and Collaborators: Masonic Cancer Center, University of Minnesota

Purpose: To study the modification of current standard of care for diffuse intrinsic pontine glioma (5,580-cGy involved-field radiation), with the final two doses of radiation given at intervals during the vaccination phase of treatment

Ages Eligible for Study: 3 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Dose-limiting toxicity (time frame: within 24 hours of vaccination)

Principal Investigator: Christopher Moertel, MD, Masonic Cancer Center, University of Minnesota; 612-626-2778, moert001@umn.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01400672

Study Type: Phase I/II/interventional/nonrandomized

Study Title: Phase I/II Trial of Mithramycin in Children and Adults With Refractory Extracranial Solid Tumors (Phase I) or Ewing Sarcoma and EWSFLI1 Fusion Transcript (Phase II)

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate whether mithramycin can be used to treat solid tumors and Ewing sarcoma in children and adults

Ages Eligible for Study: 1 year and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Phase I: Determine the tolerability, toxicity, and recommended dose of mithramycin in pediatric patients with extracranial tumors (time frame: 2 years). Phase II: Determine response in children and adults with Ewing sarcoma (time frame: 2 years).

Principal Investigator: Brigitte C. Widemann, MD, National Cancer Institute; 301-496-7387, widemanb@pbmac.nci.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01610570

Study Title: A Phase 1/2 Study of AZD1775 (MK-1775) in Combination With Oral Irinotecan in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and best dose of WEE1 inhibitor MK-1775 and irinotecan hydrochloride in treating younger patients with solid tumors that have recurred or that have not responded to standard therapy

Ages Eligible for Study: 1 to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose defined as the maximum doses of WEE1 inhibitor MK-1775 and irinotecan hyrdochloride at which fewer than one-third of patients experience dose-limiting toxicities when receiving their combination (time frame: 21 days)

Principal Investigator: Kristina A. Cole, MD, PhD, COG Phase I Consortium; 267-426-2285, colek@email.chop.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02095132

Study Title: Treatment of Neuroblastoma and GD2-Positive Tumors With Activated T Cells Armed With OKT3 X Humanized 3F8 Bispecific Antibodies (GD2Bi): A Phase I/II Study

Study Sponsor and Collaborators: Barbara Ann Karmanos Cancer Institute; National Cancer Institute

Purpose: To study the side effects and best dose of activated T cells armed with GD2 bispecific antibody and how well they work in treating patients with neuroblastoma, osteosarcoma, and other GD1-positive solid tumors

Ages Eligible for Study: 13 months to 29 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of GD2Bi-aATC (time frame: 35 days)

Principal Investigator: Maxim Y. Yankelevich, MD, Barbara Ann Karmanos Cancer Institute; 313-745-5516, myankele@med.wayne.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02173093

Study Type: Phase II/interventional/randomized

Study Title: Pilot Study to Prevent Nephrotoxicity of High-Dose Methotrexate by Prolonging the Infusion Duration and Prevent Nephrotoxicity and Ototoxicity of Cisplatin With Pantoprazole in Children, Adolescents, and Young Adults With Osteosarcoma

Study Sponsor and Collaborators: Children’s Hospital of Philadelphia; Gateway for Cancer Research

Purpose: To evaluate new approaches to prevent treatment side effects in patients with osteosarcoma without interfering with the beneficial effects of chemotherapy

Ages Eligible for Study: 1 to 30 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Change of urinary biomarker concentration from pretreatment and 24 hours after cisplatin or high-dose methotrexate (time frame: pretreatment and 24 hours after cisplatin or high-dose methotrexate)

Principal Investigator: Frank M. Balis, MD, Children’s Hospital of Philadelphia; balisf@email.chop.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01848457

Study Title: A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: To determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5-mm clinical target volume margin in combination with proton therapy

Ages Eligible for Study: up to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy (time frame: 5 years)

Principal Investigator: Thomas E. Merchant, DO, PhD, St. Jude Children’s Research Hospital; 866-278-5833, info@stjude.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01419067

Study Title: A Reduced-Intensity Conditioning Regimen With CD3-Depleted Hematopoietic Stem Cells to Improve Survival for Patients With Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: To help improve overall survival with haploidentical stem cell transplant in patients with high-risk hematologic malignancies by limiting the complication of graft-vs-host disease, enhancing post-transplant immune reconstitution, and reducing nonrelapse mortality

Ages Eligible for Study: up to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To determine whether 1-year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced-intensity conditioning regimen and a targeted-dose T cell–depleted donor product (time frame: 1 year post-transplant)

Principal Investigator: Brandon Triplett, MD, St. Jude Children’s Research Hospital; 866-278-5833, info@stjude.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00566696

Study Title: Music Video for AYA-Parent Communication and Resilience

Study Sponsor and Collaborators: Children’s Oncology Group; National Cancer Institute

Purpose: To evaluate how well music therapy and parents’ education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents

Ages Eligible for Study: 11 to 24 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Adolescent and young adult illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale (time frame: up to 90 days)

Principal Investigator: Joan Haase, PhD, RN, Children’s Oncology Group; 317-278-7749, johaase@upui.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01556256

Study Type: Phase III/interventional/randomized

Study Title: A Phase III Randomized Trial for Newly Diagnosed High-Risk B-Lymphoblastic Leukemia (B-ALL) Testing Clofarabine in the Very High Risk Stratum

Study Sponsor and Collaborators: Children’s Oncology Group; National Cancer Institute

Purpose: To investigate how effective combination chemotherapy is in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia

Ages Eligible for Study: 1 to 30 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Comparison of disease-free survival of children with high-risk acute lymphoblastic leukemia receiving postinduction intrathecal triple therapy on a modified Berlin-Frankfurt-Munster interim maintenance high-dose methotrexate backbone compared to age-adjusted intrathecal methotrexate (time frame: at 5 years)

Principal Investigator: Michael Burke, MD, Children’s Oncology Group. See clinical trial details for contact information by state.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01406756 ■