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Stage I-II

TITLE:

GM-CSF/multi peptide Vaccine Trial:  Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients with A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial to Assess Safety and Immunity

IRB #:

NCI #5906

SITE: MSKCC
PI: Dr Jedd Wolchok
CONTACT: 212-639-6570
TITLE: GP100 Vaccine Trial: Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients with Human and Mouse Gp100 DNA: A Phase I Trial to Assess Safety and Immune Response 
SITE: MSKCC
PI: Dr. Jedd Wolchok
CONTACT: 212-639-6570
TITLE: NY-ESO-1 protein vaccination in malignant melanoma administered with Imiquimod as adjuvant
IRB #: 12514
SITE: NYU Clinical Cancer Center
PI: Nina Bhardwaj, MD, PhD
CONTACT: 212-731-5401 or Elizabeth.hardin@nyumc.org
TITLE: A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells versus Montanide as Adjuvants to Stimulate anti-tumor Immunity
IRB #: 11889
SITE: NYU Clinical Cancer Center
PI: Nina Bhardwaj, MD, PhD
Contact: 212-731-5401 or Elizabeth.hardin@nyumc.org
TITLE: Injection of AJCC Stage IIb, IIc, III and IV Melanoma patients with a Multi-Epitope Peptide Vaccine using GM-CSF DNA as an Adjuvant: A Pilot Trial to Assess Safety and Immunity.
IRB #: 00-142
SITE: MSKCC
PI: Dr. Perales
CONTACT: 212-639-8682
TITLE: A Model for Genetic Susceptibility: Melanoma.
IRB #: 99-87
SITE: MSKCC
PI: Dr. Begg
CONTACT: 212-639-2000
TITLE: Prime-boost Immunization of AJCC Stage IIb, IIc, III and IV Melanoma Patients with Plasmid DNA and Poxviruses Encoding Tyrosinase: A Phase I Trial to Assess Safety and Immune Response
IRB #: Pending
SITE: MSKCC & CUMC
PI: Dr. Jedd Wolchok, Dr. Howard Kaufman (Co-PI)
Contact: 212-639-6570, 212-342-0232
TITLE: A Phase II Trial of Isolated Limb Infusion with Melphalan and Dactinomycin for Regional Melanoma and Soft Tissue Sarcoma of the Extremity.
IRB #: 99-47
SITE: MSKCC
PI: Dr. Mary Brady
Contact: 212-639-7989

Stage III-IV

TITLE: A Phase II Study of BAY 43-9006 (NCS 724772) in Stage IV Malignant Melanoma (IND 69,896)
IRB #: 12448
SITE: NYU Clinical Cancer Center
PI: Anna Pavlick, DO
Contact: 212-731-5401 or Elizabeth.hardin@nyumc.org
TITLE: Medarex Trial: Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination W/ A Melanoma Peptide Vaccine, & Melanoma Vaccine Monotherapy in HLA-A*0201-Positive Pts W/ Previously Treated Unresectable Stage III Or IV Melanoma.
IRB #: 04-125,  7729
SITE: MSKCC, CUMC
PI: Dr. Jedd Wolchok, Dr. Howard Kaufman
Contact:

212-639-6570, 212-342-0232 or gd2023@columbia.edu

TITLE: Temozolomide Trial:  Phase II Trial of Extended-Dosing Temozolomide in Patients with Melanoma .
IRB #: 00-142
SITE: MSKCC
PI: Dr Paul Chapman
Contact:

212-639-5015

TITLE: A Phase II Study of the Efficacy, Safety and Immunogenicity of ONCOVEX in Patients with Inoperable Malignant Melanoma.
IRB #: 4664
SITE: CUMC
PI: Dr. Howard Kaufman
Contact:

212-342-0232 or gd2023@columbia.edu

TITLE: Dendritic Cell Vaccine Trial: Immune Responses to Antigen-Bearing Dendritic Cells in Patients with Malignancy - A Phase I Trial in Melanoma
IRB #: 98-098
SITE: MSKCC
PI: Dr James Young
Contact: 212 639-7989
TITLE: Intra-lesional rF-B7.1 versus rF-TRICOM in the Treatment of Metastatic Melanoma.
IRB #: 14535
SITE: CUMC
PI: Dr. Howard Kaufman
Contact: 212-342-0232 or gd2023@columbia.edu
TITLE: A Phase I Study of gp75 DNA Vaccine in Patients with AJCC Stg III and IV Melanoma.
IRB #: 00-131
SITE: MSKCC
PI: Dr. Jedd Wolchok
Contact: 212-639-6570
TITLE: Injection of AJCC Stage IIb, IIc, III and IV Melanoma patients with a Multi-Epitope Peptide Vaccine using GM-CSF DNA as an Adjuvant: A Pilot Trial to Assess Safety and Immunity.
IRB #: 00-142
SITE: MSKCC
PI: Dr. Perales
Contact: 212-639-8682
TITLE: Study of Peripheral Blood and/or Bone Marrow, Including Detections of Occult Metastases, in Patients with Melanoma.
IRB #: 91-125
SITE: MSKCC
PI: Dr. Daniel Coit
Contact: 212-639-8411
TITLE: The Effect of High-dose Interleukin-2 Therapy on Peripheral Blood CD4+CD25+ Regulatory Cells in Patients with Metastatic Cancer.
IRB #: 14993
SITE: CUMC
PI: Dr. Howard Kaufman
Contact: 212-342-0232 or gd2023@columbia.edu
TITLE: Prime-boost Immunization of AJCC Stage IIb, IIc, III and IV Melanoma Patients with Plasmid DNA and Poxviruses Encoding Tyrosinase: A Phase I Trial to Assess Safety and Immune Response.
IRB #: Pending
SITE: MSKCC & CUMC
PI: Dr. Jedd Wolchok & Dr. Howard Kaufman (Co-PI)
Contact: 212-639-6570 & 212-342-0232
TITLE: A Phase II Trial of a Prime-boost Immunization Strategy with Plasmid DNA and Poxviruses Encoding Tyrosinase and Concurrent High-dose Interleukin-2 in AJCC Stage IV Malignant Melanoma Patients.
IRB #: Pending
SITE: CUMC & MSKCC
PI: Dr. Howard Kaufman & Dr. Jedd Wolchok (Co-PI)
Contact: 212-342-0232 & 212-639-6570
TITLE: Phase II Trial of R115777 in Patients with Metastatic Melanoma.
IRB #: 03-141
SITE: MSKCC
PI: Dr. Paul Chapman
Contact: 212-639-5015
TITLE: A Phase II Study of Maintenance Biotherapy with Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients with Metastatic Melanoma with a Partial Response or Stable Disease after Systemic Therapy.
IRB #: 04-027
SITE: MSKCC
PI: Dr Paul Chapman
Contact: 212-639-5015
TITLE: Phase II trial of sequential high dose Interleukin-2  followed by temozolomide and GM-CSF in metastatic melanoma
IRB #: 3484
SITE:

CUMC

PI: Dr Howard Kaufman
Contact: 212-342-0232 or gd2023@columbia.edu

Key
CUMC: Columbia University Medical Center
MSKCC: Memorial Sloan Kettering Cancer Center
NYU: New York University
PI: Principal Investigator