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Head Start 4: Newly Diagnosed Children (Less Than 10 Years Old) With Medulloblastoma and Other Central Nervous System Primitive Neuro-Ectodermal Tumors: Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed By

Principal Investigator:

James Hinkley Garvin Jr, MD

Contact Number:

212-342-5162

NCT Number:

NCT02875314

Population:

Pediatrics

Phase:

IV

This is a prospective randomized clinical trial, to determine whether dose- intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing Head Start 4 Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated...
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
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...
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

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04759586

Population:

Pediatrics

Phase:

III

The purpose of this trial is to compare the effects of nivolumab with chemo- immunotherapy on people diagnosed with Primary Mediastinal B-cell lymphoma (PMBCL), an aggressive form of large B-cell lymphoma. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. These drugs effectively treat PMBCL, but are known to cause long-term side effects at high doses. Nivolumab is a type of cancer treatment which uses the immune system to fight cancer. We will be using nivolumab with chemo-immunotherapy and comparing the results with only chemo-immunotherapy in newly...
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

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04994132

Population:

Pediatrics/Adult

Phase:

III

The overall goals of this study are: 1) To find out if vinorelbine can be given safely in combination with vincristine, dactinomycin, and cyclophosphamide (together called VINO-AC with vincristine). This is Part 1 of the study. 2) To compare the effects, good and/or bad, vinorelbine has on people with high risk RMS. This is Part 2 of the study. 3) To find out if adding maintenance therapy will help get rid of the cancer and/or lower the chance that the cancer comes back. This is Part 2 of the study. Are you Eligible? (Inclusion Criteria) Patients must be ≤ 50 years of age at the time of...
A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT05095376

Population:

Adult

Phase:

III

The purpose of this study is to compare the usual radiation therapy and usual chemotherapy, temozolomide, to using the usual radiation therapy and usual chemotherapy plus the chemotherapy drug lomustine (Gleostine). Lomustine (Gleostine) is already approved by the FDA for use in brain tumors but it is usually used alone and is not the first-line choice for methylated MGMT tumors. Adding a second chemotherapy drug, lomustine (Gleostine), to usual chemotherapy and radiation therapy could extend your life or shrink or stabilize your cancer. But, it could also cause side effects, which the study...
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...
An Adaptive Phase 3, Randomized, Open-Label,Multicenter Study to Compare the Efficacy and Safety ofAxicabtagene Ciloleucel versus Standard of Care Therapy asFirst-Line Therapy in Subjects with High-Risk Large B-CellLymphoma (ZUMA-23)

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT05605899

Population:

Adult

Phase:

III

The purpose of this study is to find out if the experimental product, axi-cel, is safe and effective in treating your lymphoma, compared to standard of care (SOC) therapy (chemotherapy), which includes either R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) or DA EPOCH R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab). The experimental treatment would involve removing some of your immune cells, genetically engineering those cells to identify cancer, receiving additional therapy while you wait for those cells to...
A PHASE 3 TRIAL OF FIANLIMAB (ANTI-LAG-3) AND CEMIPLIMABVERSUS PEMBROLIZUMAB IN THE ADJUVANT SETTING INPATIENTS WITH COMPLETELY RESECTED HIGH-RISK MELANOMA

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05608291

Population:

Adult

Phase:

III

The purpose of this study is to see if the combination of fianlimab (REGN3767) and cemiplimab (REGN2810) is an effective treatment compared to pembrolizumab in participants that have had melanoma removal surgery but are still at high risk for the return of the disease. This study involves 2 study drugs: fianlimab (REGN3767) and cemiplimab (REGN2810). The study drug, fianlimab is not approved by Food and Drug Administration (FDA). The study drug, cemiplimab, is approved in the FDA for the treatment of advanced cancers but it is considered investigational in this study because it has not been...

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