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Oncology: Clinical Research Program

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Oncology: Clinical Studies Open For Enrollment

 

 

 

Lymphoma

 

 

Immunochemotherapy with Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in CAYA with recurrent refractory CD20+ Mature B-NHL

Eligibility

  • Subject is between three years and 31 years of age
  • In first or second relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02393157

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 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

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Safety and tolerability of myeloablative conditioning and autologous stem cell transplantation followed by Polatuzumab Vedotin (PV) immunoconjugate therapy in patients with B-cell non-Hodgkin and Hodgkin lymphoma

Enrollment Status: Enrolling

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between one month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure from Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults with Lymphoma (RADICAL)

Enrollment Status: Enrolling

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (003)

Eligibility

  • Subject is at least 18 years of age
  • Relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least one line of prior therapy
  • Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least two lines of prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05139017

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. (004)

Eligibility

  • Subject is at least 18 years of age
  • Has relapsed or refractory (rr) DLBCL
  • Has progressed after at least two lines of prior therapy, and
  • Has progressed after auto-stem cell transplant (SCT) or are auto-SCT ineligible
  • Must have received prior multiagent regimen that includes an alkylating agent, anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05144841

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

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

Eligibility

  • Subject is at least two years of age
  • Primary mediastinal B-cell lymphoma (PMBCL)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04759586

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

Leukemia

 

Pilot Study Using Induction Chemo-immunotherapy followed by Consolidation with Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Eligibility

  • Subject is between one year and 31 years of age
  • Patients must weigh at least 10 kilograms at the time of the study enrollment 
  • Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03719105

Principal Investigator

Aliza Gardenswartz, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic

Eligibility

  • Subject is between one year and 30 years of age
  • Disease: B-ALL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ADVL1822: A PHASE 1/2, MULTI-CENTER, DOSE-ESCALATING STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH RE-INDUCTION CHEMOTHERAPY, AND AS A SINGLE-AGENT CONTINUATION THERAPY, IN PEDIATRIC RELAPSED/REFRACTORY AML SUBJECTS AGED 1 MONTH TO < 18 YEARS (AND YOUNG ADULTS AGED UP TO 21 YEARS) WITH FLT3-ITD MUTATIONS

Eligibility

  • Subject is between one year and 21 years of age
  • AML with at least 5% blasts in bone marrow, with or without extramedullary disease
  • First relapse or refractory to first-line high-dose chemotherapy with no more than one attempt (one to two cycles of induction chemotherapy) at remission induction - prior HSCT is permitted

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03793478

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AALL1732 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

Eligibility

  • Subject is between one year and 31 years of age
  • B-cell Lymphoblastic Leukemia
  • B-cell Lymphoblastic Lymphoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914625

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML1831 CIRB, 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

Eligibility

  • Subject is no older than 22 years of age
  • Newly diagnosed with de novo AML with or without extramedullary disease
  • Patient must have one of the following:
    • At least 20% bone marrow blasts (obtained within 14 days prior to enrollment)
    • Less than 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04293562

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AALL1631, International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones

Eligibility

  • Subject is between two and 21 years of age
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03007147

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AAML18P1, Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Eligibility

  • Subject is no older than 25 years of age
  • CML-CP at original diagnosis
  • Molecular remission (MR) with a BCR-ABL1 level of no more than 0.01% BCR-ABL1

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03817398

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

Eligibility

  • Subject is 30 years of age or younger
  • Recurrent or refractory Hodgkin or non-Hodgkin Lymphoma and have failed at least one line or prior therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05255601

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

 

 

Solid Tumors


 

A Phase 1/2 Study of PBI-200 in Subjects with NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

Eligibility

  • 18 years old and older
  • Subjects with NTRK-fusion-positive solid tumors 
  • Subjects with NTRK-gene-amplified solid tumors, primary brain tumors or EWSR1-WT1-positive DSRCTs
  • Has measurable disease by RECIST v1.1 for subjects with non-brain primary tumors or RANO criteria for subjects with primary brain tumors

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | study identifier: NCT04901806

Principal Investigator

Daniel C. Cho, MD

Contact for Study Screening

Janelle.Richards@wmchealth.org

 

A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between one year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

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

Eligibility

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT)
  • Standard risk 1: Patient must be less than 11 years of age at enrollment
  • Standard risk 2: Patients must be at least 11 and less than 25 years of age at enrollment
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher)
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma; tumor markers: alpha-FP less than or equal to 1,000 ng/mL, beta-HCG institutional normal; all ages
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age less than 11 years
  • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP less than 1,000 ng/mL, beta-HCG less than 5,000 IU/mL and lactate dehydrogenase (LDH) less than 3.0 x normal; age at least 11 and less than 25 years
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age at least 11 and less than 25 years

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03067181

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ANBL1531 (CIRB): A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

Eligibility

  • Subject is between one year and 30 years of age
  • Diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • The following disease groups are eligible:
  • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:
    • MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; or
    • Age greater than 547 days regardless of biologic features
  • Patients with INRG stage MS disease with MYCN amplification
  • Patients with INRG stage L2 disease with MYCN amplification
  • Patients greater than 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within four weeks of progression to stage M
  • Patients at least 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within four weeks of progression to stage M

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03126916

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AGCT1532 A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors

Eligibility

  • Subject is between 11 - 45 years of age
  • Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma), or
  • Exceptionally raised tumor markers (AFP at least 1000ng/mL and/or HCG at least 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumor burden, and a need to start therapy urgently
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  • Metastatic disease or non-testicular primary
  • Intermediate or poor prognosis

Enrollment Status: Enrolling

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • Subject is between one month and 17 years of age
  • Newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement
  • Receiving myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB AREN1921, Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor 

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04322318

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

AHEP1531 Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Eligibility

  • Subject is no older than 30 years of age
  • Newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03533582

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A PHASE 2 STUDY OF DS-8201A (NSC# 807708, IND# 153036) IN ADOLESCENTS, OR YOUNG ADULTS WITH RECURRENT HER2+ OSTEOSARCOMA PEPN1924 

Eligibility

  • Subject is between 12 - 39 years of age
  • Osteosarcom having received at least standard initial therapy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04616560

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

CIRB,AOST2031, A Phase 3 Randomized Controlled Trial Comparing Open vs Thuoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma 

Eligibility

  • Subject is no older than 50 years of age
  • Osteosarcoma
  • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of first recurrence following completion of therapy for initially localized disease
  • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05235165

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

Eligibility

  • Subject is at least 18 years of age
  • Has previously untreated stage I or IIA Non-Small Cell Lung Cancer (NSCLC)
  • Cannot undergo thoracic surgery due to existing medical illness(es) or anatomically unresectable tumor or medically operable participants who decide to treat with SBRT as definitive therapy rather than surgery

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03924869

Principal Investigator

Mark Hurwitz, MD

Contact for Study Screening

Sooyun.Tavolacci@wmchealth.org

 

 

Brain Tumors

 

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients with Solid Tumors or Lymphomas and Treated with Myelosuppressive Chemotherapy

Eligibility

  • 1 month - 17 years of age at time of study entry
  • Has a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement 
  • Is a candidate to receive myelosuppressive chemotherapy

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04570423

Principal Investigator

Mitchell S. Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Phase 1 Study of Vorinostat in Combination with Vincristine, Irinotecan and Temozolomide in Children, Adolescents and Young Adults with Relapsed or Refractory Solid Tumors and CNS Malignancies

Eligibility

  • Subject is between one year and 30 years of age
  • Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04308330

Principal Investigator

Jeremy Rosenblum, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1422 (CIRB) A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Eligibility

  • Subject is between three years and 21 years of age
  • Classical histologic type (non LC/A) WNT medulloblastoma that is Positive nuclear beta-catenin by immunohistochemistry (IHC), Positive for CTNNB1 mutation and Negative for MYC and MYCN by fluorescence in situ hybridization (FISH); negative CNS on lumbar puncture

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02724579

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

HEAD START 4 PROTOCOL:  Newly Diagnosed Children (Less than 10 Years Old) With Medulloblastoma and Other Central Nervous System Embryonal Tumors. Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation with Randomization to either Single-Cycle or to Three Sequential Cycles of Marrow-Ablative Chemotherapy with Autologous Hematopoietic Progenitor Cell Rescue

Eligibility

  • Subject is no more than 10 years of age
  • Diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT02875314

Principal Investigator

Mitchell Cairo, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1831, CIRB A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Eligibility

  • Subject is between two and 21 years of age
  • Neurofibromatosis type 1 (NF1)
  • Newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
  • Optic pathway gliomas

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03871257

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

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)

Eligibility

  • Subject is between two and 21 years of age
  • Non-neurofibromatosis type 1 (non-NF1) low-grade glioma (LGG) without a BRAFV600E mutation
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04166409

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS1931, A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas

Eligibility

  • Subject is between two and 25 years of age
  • Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation
  • Progressive or recurrent LGG
  • Metastatic disease or multiple independent primary LGGsl
  • All tumors considered low-grade glioma or low-grade astrocytoma

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04576117

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

ACNS2021, A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Eligibility

  • Subject is between three and 30 years of age
  • Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or greater than 10 ng/mL or human chorionic gonadotropin (hCG) beta greater than 100 mIU/mL
  • Suprasellar, pineal and bifocal tumors are included
  • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04684368

Principal Investigator

Jessica Hochberg, MD

Contact for Study Screening

Lauren_Harrison@nymc.edu

 

A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

Eligibility

  • Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
  • Willing and able to provide informed consent and to participate in all evaluations

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04427384

Principal Investigator

Simon Hanft, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

 

 

Gynecology

 

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma Protocol GOG 3065/ZN-c3-004

Eligibility

  • Females at least 18 years of age at the time of informed consent
  • Recurrent or persistent Uterine Serous Carcinoma
  • Measurable disease
  • Treatment with at least one prior platinum-based chemotherapy regimen for management of advanced or metastatic USC

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04814108

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Judy.Moore@wmchealth.org

 

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination with Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Eligibility

  • Confirmed ovarian cancer (high-grade serous, endometrioid, clear cell, fallopian tube cancer or primary peritoneal cancer
  • At least 18 years of age
  • Patient must have received at least one prior line of systemic anticancer therapy
  • Patient must have received bevacizumab
  • Patient must have had PARP inhibitor therapy if BRCA mutation exists
  • Disease progression
  • Patient NO requires or has NOT taken systemic corticosteroids

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT05092360

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Judy.Moore@wmchealth.org

 

NRG GY-019- A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Eligibility

  • At least 18 years of age
  • Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer
  • Patients must be able to take oral medications
  • Patients may not have received previous hormonal therapy for the treatment of this disease
  • Patients with NO central nervous system metastases

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04095364

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Judy.Moore@wmchealth.org

 

NRG-GY018- A Phase 3 Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475) in addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Eligibility

  • At least 18 years of age
  • Diagnosis of endometrial cancer
  • Measurable stage III, measurable stage IVA, stage IVB, or recurrent endometrial cancer
  • Must have a measurable lesion on CT or MRI scan

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT03914612

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Judy.Moore@wmchealth.org

 

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of Zn-C3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma

Eligibility

  • Recurrent uterine serous carcinoma
  • Measurable disease
  • Treatment with at least one prior platinum-based chemotherapy regimen for management of advanced or metastatic uterine serous cancer
  • IF HER2 positive, patients must have received prior HER2-targeted therapy 9e.g. trastuzumab)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04814108

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Judy.Moore@wmchealth.org

 

A Phase 2 Open-label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations

Eligibility

  • At least 18 years of age
  • Locally advanced or metastatic malignancy
  • Solid tumor with one or more relevant genetic alterations in DDR-related genes. These are defined as pathogenic (deleterious) mutations in the MRN complex genes (MRE11, RAD50, or NBN) or CCNE1 amplifications
  • Must have received prior standard therapy appropriate for their tumor type and stage of disease
  • Must have at least one measurable lesion
  • No major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration)

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04158336

Principal Investigator

Tana Pradhan, MD

Contact for Study Screening

Judy.Moore@wmchealth.org

 

Urology

 

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Eligibility

  • At least 18 years of age
  • Metastatic Renal Cell Carcinoma disease
  • Subjects who are candidates for standard of care immunotherapy
  • No history of or known brain metastases, spinal cord compression, carcinomatous meningitis, or evidence of brain or leptomeningeal disease

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04203901

Principal Investigator

John Phillips, MD

Contact for Study Screening

Lauren.Washco@wmchealth.org

 

A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma

Eligibility

  • Subject is at least 18 years of age
  • Advanced disease histologically assessed as RCC, with predominantly clear cell histology
  • Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of study participation per iRECIST
  • Subjects who are candidates for standard first-line therapy
  • Time from initial RCC diagnosis to initiation of systemic treatment (Nivolumab+Ipilimumab) of less than one year
  • Karnofsky Performance Status (KPS) great than or equal to 70%
  • Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade less than or equal to one according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
  • Adequate hematologic function, as defined by central laboratory values for all three of the following criteria:
    • Absolute neutrophil count (ANC) LLN, and
    • Platelets 75,000/mm3 or 75.0 x 109/L, and
    • Hemoglobin (Hgb) 8.0 g/dL
  • Adequate renal function, as defined by either of the following criteria:
    • Serum creatinine 1.5 x upper limit of normal (ULN), or
    • If serum creatinine greater than 1.5 x ULN, estimated glomerular filtration rate (eGFR) 30 mL/min
  • Adequate hepatic function, as defined by both of the following:
    • Total serum bilirubin 1.5 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN or, AST and ALT 5 x ULN if liver function abnormalities are due to underlying malignancy
  • Adequate coagulation function as defined by either of the following criteria:
    • INR less than 1.5 x ULN
    • For subjects receiving warfarin or LMWH, the subjects must, in the investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these patients may exceed 1.5 x ULN if that is the goal of anticoagulant therapy.
  • Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug
  • Normal ECG or clinically non-significant finding(s) at Screening, in the Investigator's opinion
  • Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04203901

Principal Investigator

John Phillips, MD

Contact for Study Screening

John_Phillips@nymc.edu