SANTOSH  KESARI,  MD, PhD

For more information on clinical trials and enrollment, please contact our clinical trials coordinators:
Marlon Saria at
sariam@jwci.org

 LIST  OF NEURO-ONCOLOGY CLINICAL TRIALS

THERAPEUTIC OPPORTUNITIES FOR BRAIN TUMOR PATIENTS

CLINICAL RESEARCH  IN NEURO-ONCOLOGY

NEWLY DIAGNOSED
GBM

CLOSED. NW Biotherapeutics (IRB 111800) – Brad: A Phase II Clinical Trial Evaluating DCVax-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme

CLOSED. Brown Univ/Cell Therapeutics (IRB 120697) – Pamela: A Phase 2 Study BrUOG 244, PPX and Concurrent Radiation for Newly Diagnosed GBM without MGMT Methylation

CLOSED.  Celldex CDX110-04 (IRB 120880) – Brad: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The ACT IV Study)

CLOSED. NovoCure EF-14 (IRB 081483) – Pamela: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM 

ANAPLASTIC GLIOMA

N0577 NCT00887146 (IRB 131042) – Pamela: Phase III Intergroup Study of Temozolomide Alone vs. Radiotherapy with Concomitant and Adjuvant Temozolomide vs. Radiotherapy with Adjuvant PCV Chemotherapy in patients with 1p/19q Co-deleted Anaplastic Glioma

RECURRENT
GBM/Anaplastic Glioma

AngioChem ANG1005-CLN-03 (IRB 131256) - Pamela: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients with Recurrent High-Grade Glioma
GenSpera G-202 (IRB 131124) – Lara:  An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 in Patients with Recurrent or Progressive Glioblastoma

Novartis (IRB 091728) – Pamela: A phase I/II Study of PDGFR Kinase Inhibitor in Biomarker-enriched Recurrent Malignant Gliomas (ANY GRADE WITH PDGFR +)

Sunovion Pharma (IRB 121417) – Pamela: Phase 1, Open-Label, Dose-Escalation Study in Adult Patients with Advanced Malignancies (NSCLC, Ovarian, GBM, AML) Known to Overexpress the WT1 Protein (Vaccine with Induction, Consolidation, Maintenance Phases)

UCSD/E-Therapeutics (IRB 111827) – Lara:  A Phase I, Sequential Cohort, Open-Label, Dose-escalation Study of the Safety, CNS Pharmacokinetics and Preliminary Efficacy of Dexanabinol in Patients with Brain Cancer

Tocagen Toca 511-08-01 (IRB 110634) – Lara: A Phase I Ascending Does Trial of the Safety and Tolerability of Toca 511 in Patients with Recurrent High Grade Glioma. (biopsy+Toca511)

Tocagen Toca 511-11-01 (IRB 121322) – Lara: A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma and Followed by Treatment with Toca FC, Extended Release 5-FC. (surgery+Toca511).

EMR 100018-001 (IRB: 116341) – Brad:  A Phase I, First in Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects with Advanced Malignancies

RTOG 1205 (IRB 130200) – Mary: Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irridation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma.

METASTATIC TRIALS


UCSD/Pfizer (IRB 130418) - Pamela: A Phase II Study to Evaluate the Efficacy, Safety, and CNS Pharmacokinetics of the HER Family Inhibitor Dacomitinib (Pfizer drug) in Progressive Brain Metastases
Kadmon KD019-204 (IRB 140781) – Pamela: A Phase 1b/2a Study of the Combination of KD019 and Trastuzumab in Subjects with HER2-Positive Metastatic Breast Cancer

AngioChem ANG1005-CLN-04 (IRB 140815) – Pamela: A Phase II, Open-Label, Multi-Center Study of ANG1005 in HER2-Positive Breast Cancer Patients with Progressive/Recurrent Brain Metastases

CALGB 51101 (IRB: 140120) – Brad:  A RANDOMIZED PHASE II TRIAL OF MYELOABLATIVE VERSUS NON-MYELOABLATIVE CONSOLIDATION CHEMOTHERAPY FOR NEWLY DIAGNOSED PRIMARY CNS B-CELL LYMPHOMA

NONTHERAPEUTIC TRIALS

Alliance A221101 (IRB 131180) - Lara:  A Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with Glioblastoma MultiformeCaregiver Research (IRB 13-001619) – Marlon:  An exploratory study of caregiver burden among caregivers of cancer patients with brain metastasis

Imaging Study – Brad:  Quantitative Neuroimaging and Neurocognitive Assessment to Measure Radiation-Induced Brain Injury in Non-targeted Tissue: Implications for Cognitive Preservation

At the Division of Neuro-Oncology, we strive to provide compassionate and state-of-the-art clinical care for patients with primary and metastatic brain cancers. We treat patients at the John Wayne Cancer Institute at
Providence Saint John’s Health Center along with our
team at Pacific Brain Tumor Center.

We aim to develop and bring novel therapeutics to patients with brain cancers. We have innovative clinical trials for patients with primary brain tumors like glioblastoma. We also have clinical trials for patients with cancer that have metastasized to the brain from the periphery (for instance, from the breast, prostate, melanoma, etc.).

TRANSLATIONAL NEURO-ONCOLOGY LABORATORIES (TNOL)