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AREN1721: A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single AgentAxitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC)Across All Age Groups

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03595124

Population:

Pediatrics/Adult

Phase:

II

This phase 2 study is examining the best treatments for TFE/Translocation type Renal Cell Carcinoma (tRCC). The best treatment for this type of kidney cancer is not known. This study is looking at 3 different treatment plans and trying to determine which treatment plan will be best. Are you Eligible? (Inclusion Criteria) Patients must be at least 12 months of age Patients may be newly diagnosed or previously received treatment Patients must also meet all eligibility criteria as outlined in the study protocol
A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging

Principal Investigator:

Andrew B. Lassman, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04691960

Population:

Adult

Phase:

II

The purpose of the study is to evaluate the tolerability of a ketogenic diet in conjunction with metformin in people with malignant glioma. The study doctors will try to determine if maintaining the ketogenic diet with metformin will have any effect on your tumor. Are you Eligible? (Inclusion Criteria) Have you been diagnosed with high-grade glioma? Are you 18 years of age or older? Do you not have Type 1 or Type 2 diabetes? Have you not received prior treatment with Bevacizumab and are you not receiving any other investigational agents?
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Principal Investigator:

Gary K Schwartz, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04044768

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find out if an investigational drug, called ADP-A2M4, is safe and how well it works in attacking Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) cancer cells. The study involves taking certain types of immune cells from the blood, called T cells, and changing them in a laboratory before putting them back into the bloodstream, with the aim of helping them to attack and kill cancer cells. It is hoped to learn if these genetically changed T cells are safe and work to kill these cancer cell types. Are you Eligible? (Inclusion Criteria) Are you between the...
ANBL1821: A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03794349

Population:

Pediatrics

Phase:

II

The goal of this study is to utilize eflornithine (DFMO) to improve response rates in patients with relapsed neuroblastoma in combination with dinutuximab/irinotecan/temozolomide compared to patients assigned to receive dinutuximab/irinotecan/temozolomide alone. DFMO works to inhibit ODC1, an enzyme in the tumor growth pathway. Are you Eligible? (Inclusion Criteria) Patients must be diagnosed with active relapsed, refractory or progressive disease. Patients must have histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow...
ACNS1723: A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03919071

Population:

Pediatrics

Phase:

II

The purpose of this study is to see if using two drugs called dabrafenib and trametinib after radiation treatment will be better than treatments used in the past in improving survival for patients with newly-diagnosed high grade glioma (HGG) that have the BRAF V600-mutation (a gene change within tumor cells). It is expected that the combination of these two medications that target the gene change and its cellular growth pathway will demonstrate clinical success when given as maintenance therapy following standard radiation therapy. Treatment on this study may last for approximately 2 years...
ADVL1823: Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT03834961

Population:

Pediatrics

Phase:

II

The purpose of this study is to determine how well Larotrectinib works in treating patients with newly diagnosed TRK fusion solid tumors or relapsed or refractory TRK fusion acute leukemias. TRK fusion means that you have a change in the TRK gene in your tumor. Larotrectinib is a highly selective oral small molecule inhibitor of the TRK family of tyrosine kinases, which are encoded by the NTRK genes. Are you Eligible? (Inclusion Criteria) Patient must be 30 years of age or younger at time of study entry Patient must have: Cohorts A & B: newly diagnosed infantile fibrosarcoma or any solid...
A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell LungCancer whose Disease has Progressed on First-Line Osimertinib Therapy (ORCHARD)

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03944772

Population:

Adult

Phase:

II

The purpose of this study is to gain a better understanding of why some patients with non-small sell lung cancer and a epidermal growth factor receptor (EGFR-sensitizing mutation, fail first-line treatment with the drug osermitinib. Additionally, the purpose is to explore different drug therapies for patients whose cancer has progressed (gotten worse) after treatment with osermitinib, and to evaluate each therapy's safety and how effective each is at treating cancer. Each patient will be evaluated for mutations that might have made them resistant to osermitinib. Patients with certain...
ADVL1521: A Phase 2 Study of the MEK inhibitor Trametinib (IND #119346, NSC# 763093) in Children with Relapsed or Refractory Juvenile Myelomonocytic Leukemia

Contact Number:

(212) 342-5162

NCT Number:

NCT03190915

Population:

Pediatrics

Phase:

II

This study is for children with Juvenile Myelomonocytic Leukemia (JMML) that has come back (relapsed) or not responded to treatment (refractory). The overall goal is to find out what effects, good and/or bad, the study drug, Trametinib, has on people with JMML. In addition, the study is trying to determine how well Trametinib works to treat JMML. Trametinib is a drug that works to target certain gene changes (mutations) commonly found in JMML leukemia cells. Are you Eligible? (Inclusion Criteria) Patient must be greater than 1 month and less than 22 years of age at study entry Patient must...
An Open-Label, Phase II Multicenter Study of Rituximab or Tocilizumab for Steroid-Dependent Immune-Related Adverse Events due to Immune Checkpoint Blockade.

Principal Investigator:

Brian Henick, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04375228

Population:

Adult

Phase:

II

The purpose of this study is to determine the safety and effectiveness of two drugs, either rituximab or tocilizumab, in patients who develop side effects while on treatment with immunotherapy requiring prolonged steroids. Immune-related side effects are caused by activation of the immune system from treatment with immunotherapy. Both rituximab and tocilizumab have been given to patients with autoimmune diseases (diseases where the immune system is activated against normal organs). Immune-related side effects appear to closely mirror these autoimmune conditions. Are you Eligible? (Inclusion...
A SINGLE ARM, MULTICENTER, PHASE II, OPEN-LABEL TRIAL TO EVALUATE EFFICACY OF ISATUXIMAB IN PATIENTS WITH MONOCLONAL GAMMOPATHY OF RENAL SIGNIFICANCE

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT04614558

Population:

Adult

Phase:

II

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with Monoclonal Gammopathy of Renal Significance (MGRS). Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treatMonoclonal Gammopathy of Renal Significance (MGRS). This means that the use of isatuximab in this study is considered ‘investigational’. Are you Eligible? (Inclusion Criteria) • Are you 18 years of age or older? • Do you have persistent renal...

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