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AGCT1531 - A Phase 3 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

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03067181

Population:

Pediatrics/Adult

Phase:

III

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Are you Eligible? (Inclusion Criteria)...
ANBL1531, A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or AlK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03126916

Population:

Pediatrics/Adult

Phase:

III

This randomized clinical trial is examining whether the addition of radio- labelled MIBG or Crizotinib will improve the survival of high risk Neuroblastoma patients, as compared to standard treatment. Patients will be non-randomly assigned to Crizotinib based on tumor testing. All other patients will be randomized to receive standard therapy or standard therapy + MIBG. Are you Eligible? (Inclusion Criteria) Between 1 and 30 years of age Have a diagnosis of High Risk Neuroblastoma Enrolled on ANBL00B1 Patients must also meet all other eligibility criteria as outlined in the study
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

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04293562

Population:

Pediatrics

Phase:

III

This is a Phase 3 trial that will compare the efficacy of CPX-351 (a combination of 2 standard chemotherapy medicines - Daunorubicin and Cytarabine) compared to standard chemotherapy in the treatment of Acute Myelogenous Leukemia (AML). Patients will be randomly assigned by a computer to receive treatment with either CPX-351 treatment regimen or the standard chemotherapy regimen. In addition, if testing shows that a patient's AML has a specific gene change (FLT3), then those patients will be offered treatment with a new medicine (Gilteritinib) that targets the FLT3 gene change. For all...
AGCT1532: Phase 3 Accelerated BEP Trial:A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT02582697

Population:

Pediatrics/Adult

Phase:

III

This is a study for patients between 11 years and 45 years who have newly diagnosed intermediate or poor-risk metastatic germ cell tumors (GCTs). This study is looking at whether giving treatment with Bleomycin, Etoposide, and Cisplatin (BEP)every 2 weeks (accelerated BEP) or every 3 weeks (standard BEP) is better. Participants will be randomized to either Arm A: standard BEP or Arm B: accelerated BEP. All participants will receive a medication to stimulate the body to make white blood cells which has allowed some chemotherapy regimens to be given with a shorter than usual cycle length, while...
A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05232916

Population:

Adult

Phase:

III

The purpose of this research is to test how well an investigational study drug (medication), GLSI-100, can prevent your cancer from coming back. The research study will also collect information about the safety of the medication. The research will also study how the medication works and who responds the best to the medication. GLSI-100 is a combination of a study medication called GP2 and the FDA-approved medication, granulocyte-macrophage colony-stimulating factor (GM-CSF) or sargramostim (Leukine®). It is thought that this medication will work by helping your immune system identify and...
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT05675410

Population:

Pediatrics/Adult

Phase:

III

This Phase III trial investigates if the incorporation of immunotherapy will improve progression-free survival (PFS) and maintain overall survival (OS) while simultaneously minimizing long-term morbidity and treatment-related mortality by reducing exposure to radiotherapy and high cumulative chemotherapy doses. The study will enroll patients ages 5 to 60 years with newly diagnosed early-stage cHL and will investigate the targeted CD30-antibody drug conjugate, Brentuximab Vedotin (Bv), with PD-1 blockade (nivolumab) compared with a standard chemotherapy regimen, with or without RT Are you...
AALL 1732: A Phase 3 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

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03959085

Population:

Pediatrics/Adult

Phase:

III

AALL1732 is a Children’s Oncology Group (COG) group-wide Phase 3 study for patients between the ages of 1-25 years with newly diagnosed high risk B-lymphoblastic leukemia (HR B-ALL), mixed phenotype acute leukemia (MPAL), or disseminated (Murphy stage III or IV) B-lymphoblastic lymphoma (B-LLy). Patients with HR B-ALL will be stratified into HR favorable B-ALL (HR-Fav) or HR B-ALL, and this study will assess whether the incorporation of two blocks of inotuzumab ozogamicin (InO) into a modified Berlin- Frankfurt-Münster (mBFM) chemotherapy backbone will improve the disease-free...
A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT05304585

Population:

Pediatrics/Adult

Phase:

III

Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in children and adolescents, with approximately 350 children diagnosed annually in the United States. Patients are divided into low, intermediate, and high-risk groups based on the characteristics of their disease. The overall goals of this study are: 1. To compare the effects, good and/or bad, of giving less chemotherapy drugs to people with VLR-RMS to find out which is better. This is Arm VLR-RMS of the study. 2. To find out how well people with LR-RMS as a group respond to standard chemotherapy when risk groups are refined so...
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

Principal Investigator:

Brian John Andrew Gill, MD

Contact Number:

212-342-5162

NCT Number:

NCT05902169

Population:

Adult

Phase:

III

The purpose of this study is to see if the implantable device, Sonocloud 9, is effective getting chemotherapy to better reach your tumor compared to receiving standard of care chemotherapy [Temozolomide and Lomustine] and to see how safe and tolerable the device is. Sonocloud 9 works by making the blood-brain barrier (BBB) more permeable(allowing liquids or gases to go through it) so chemotherapy can better reach your tumor. The BBB is a natural sealing of the blood vessels in the brain. This study is being done in participants whose brain tumor has returned and are eligible for surgery to...
A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with OsteosarcomaAn Intergroup NCTN Phase 3 Study

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT05235165

Population:

Pediatrics/Adult

Phase:

III

This study will be the first randomized controlled trial of surgical approach for pulmonary metastatic osteosarcoma. The study will randomize surgical resection of pulmonary metastases between Open surgery (thoracotomy or sternotomy) and minimally invasive Thoracoscopy. Primary outcome will be thoracic event free survival (thoracic event is defined as intrathoracic tumor recurrence by chest CT or death that results from the procedure or a complication related to the procedure). Correlative outcomes include quality of life from patient-reported outcomes, along with imaging and laboratory...

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